Download Therapeutic Protein Immunogenicity Focus Group (TPIFG)

Biotech Section Newsletter
Volume 1, Issue 2
July 2012
Sponsored by the
Therapeutic Protein Immunogenicity Focus Group (TPIFG)
In this issue
Editor’s Note
Biotech Section of AAPS
About us: TPIFG
 Message from the TPIFG Chair
 TPIFG Action Program Committee Updates
Scientists’ Contributions
 Technique-Review: Protein Profiling on Nitrocellulose-Coated Slides: A Novel
Biomarker Screening and Validation Tool for Cell Isolates and Hair Follicles
 Mini-Review: Controlling the Adverse Effects of Anti-Drug Antibodies
 Sterile Products Focus Group
Students’ Corner
 TPIFG Student Education
 Mark your calendar
 Technique-Review: Proteins and Tangential Flow Filtration
 Biologics: Approvals/ Recalls
 NBC 2012 Highlights:
Sunrise Session
Open Forum
Experience as Student Co-Moderators/Moderators
Awards
Announcements
1
Editor’s Note
Dear Biotec Section Members
I hope those of you who attended the National Biotechnology Conference (NBC) in San Diego enjoyed the
proceedings and found time to network and develop new friendships. Meetings such as these only succeed due to
the support and active participation of members like you and your willingness to share the breadth of your
knowledge and experiences.
The Therapeutic Immunogenicity Focus Group (TPIFG) is delighted to host the Biotec Section newsletter this
quarter. Although this focus group has been around for about 5 years, it has had a huge impact on the AAPS
community and has highlighted specific challenges in biotherapeutics development as it relates to the understanding
of clinical sequelae of immunogenicity and immunogenicity prediction and mitigation. The July newsletter contains
updates from each of the action program areas of the TPIFG to highlight the progress made in the various areas. In
addition, there are some interesting scientific articles contributed by AAPS members at large. A feature on the
Sterile Products Focus Group in this edition of the newsletter is intended to educate the readership about the mission
and vision of the group. Also, the Biotec student chapter has contributed articles on student education, NBC meeting
sessions, the immunogenicity open forum as well as on the experience of students who served as moderators for the
various sessions at the NBC 2012. Do not miss the pictures from the Biotec section meeting and executive
committee dinner that was hosted at NBC 2012!
With summer upon us what better way to spend time than perusing the Biotec Section newsletter and learning
something new about the industry and your colleagues. As always, the various focus groups are looking for
volunteers. I hope that you will consider volunteering and will find it a rewarding experience.
I want to take this opportunity to express my sincere thanks to Suprita Tawde (Mercer University) and
Persymphonie Miller (Jannsen R&D) for their phenomenal work in collating the content and designing this
newsletter.
Enjoy!
Meena Subramanyam
2
Biotech Section of AAPS
The BIOTEC section of AAPS is comprised of members from many diverse backgrounds in industry and academia
who share a common interest in the evolving field of biotechnology. The primary goal of this section is to unite
multiple scientific disciplines in a forum where they can share experimental results as well as concerns regarding the
research, development, and commercialization of new biotechnology based pharmaceuticals.
Here are some statistical numbers indicating the progress of the Biotech section so far:
Total Number of Attendees at NBC
2012
Total number of Abstracts presented
at NBC
1482
2011
281
1635
196
2010
1372
2009
2008
149
55
RS
4%
PPDM
17%
PPB
4%
Biotech
43%
MSE
2%
FDD
11%
DDDI
2%
CPTR
13%
APQ
4%
2012
2011
2010
2009
2008
1446
2007
2006
2006
1474
2004
2007
2002
1239
NBC 2012 Programming Statistics
3
222
178
130
1464
274 279
Biotech Section of AAPS
cont.
2012 AAPS Committee Representatives
AAPS COMMITTEE
Annual Meeting Program Committee (AMPC)
BIOTEC REPRESENTATIV E
Bill Nowatzke
Content Advisory Committee (CAC)
Masood Khan
Student/PostDoc Outreach & Development (SPOD) Committee
Franklin Spriggs
Fellows Committee
Steve Swanson
Nominations Committee
Binodh DeSilva
2013 National Biotechnology Conference Program Committee
Kamal Egodage
2013 National Biotechnology Conference Screening Committee Thorsten Verch
Annual Meeting Screening Committee
Shalini Gupta
Program Coordination Committee (PCC)
Mary Cromwell
Membership Strategic Oversight Committee
Mark Ma
Biotec Section Executive Committee 2011-2012
Section Committee
Representative
•
Chair- Binodh DeSilva
Student Representative
Prathap Shastri
•
Past Chair-Mary Cromwell
Awards Committee
Mary Cromwell
•
Chair Elect- Bill Nowatzke
Publications Committee
Chris Beaver
•
Vice-Chair- Tapan Das
Membership Committee
Karina Kwok
•
Secretary/Treasurer - Meena Subramanyam
Webmasters Committee
Tarik Khan
Webinar / Open Forum /
Mary Cromwelll
Workshop Committee
4
Biotech
Section
Editor’s
Noteof AAPS
cont.
AAPS-Biotech Section Focus Groups (FGs) and their Chairs
FG: Protein Aggregation
Karoline Bechtold-Peters
FG: Ligand Binding Assay Bioanalytical
Phillip Oldfield
FG: Biotherapeutics ADME
Steven Martin
FG: Therapeutic Protein Immunogenicity
Gopi Shankar
FG: Biomarkers in Translational Medicine
Tim Wyant
FG: Pharmaceuticals in Global Health
Kishor Wasan
FG: Pharmacogenomics (PGx)
Pramod Mahajan
FG: Preformulation
Maria Polikandritou-Lambros
FG: Sterile Products
Aniket Badkar
FG: Systems Biology
Di Wu
FG: Lipid Based Drug Delivery Systems
Anette Mullertz
FG: Computational Drug Design
Herschel Weintraub
FG: Generic Pharmaceuticals
Raja Velagapudi
Our Student Committee
BSSC Past Chair
Tarik Khan
BSSC Chair
Prathap Shastri
BSSC Chair-Elect/Vice Chair
Tracy Ooi
BSSC Secretary
Yan Wang
BSSC NBC Liaison
Sophia Ononye
[Courtesy: Binodh DeSilva, Teresa Homrich, Kamal Egodage, Trish Smith, Kate McHugh, Maria Nadeau,
Gopi Shankar]
5
AAPS Therapeutic Protein Immunogenicity
Focus Group (TPIFG)
MESSAGE FROM THE TPIFG CHAIR
Time passes by so quickly it seems... It’s hard for me to believe that nearly 3 years
have passed since Dr. Bonita (Bonnie) Rup and I initiated the Therapeutic Protein
Immunogenicity Focus Group (TPIFG). Bonnie chaired our newly formed focus
group for a year and her tutelage was invaluable to me. We formed a Steering
Committee, detailed our objectives, created five focused Action Program Areas
(APAs), and began our work.
Gopi Shankar, Ph.D., MBA
In October I will finish my 2-year term and move on to become Past-Chair. Dr.
Valerie Quarmby will take on the reins as the Chairperson, and Dr. Susan Richards will start her tenure as Vice
Chair (a.k.a. Chair Elect). Bonnie’s and my vision for TPIFG was shared by others who joined us and contributed
their time and efforts to our focus group. For that I am grateful to my other Steering Committee members: Dr.
Meena Subramanyam, Dr. Jeff Sailstad, Dr. Eric Wakshull, Mr. Tarik Khan, and Ms. Suprita Tawde. In the last 2
years TPIFG has made significant contributions to AAPS - both the National Biotechnology Conference (NBC) and
the Annual Meeting (AM) - through our five areas of focus:

Uniform Reporting of Data

Immunogenicity Prediction

Immune Mitigation

Communications

Programming
Starting a focus group is not trivial – not only does it involve gap identification in a scientific discipline that could
be addressed via cross-company, academic and/or regulatory collaborations, it also includes clear definition of
scope, enhancement of cross-focus group and cross-section collaborations within AAPS, soliciting preliminary
BIOTEC Section Meeting and Reception at the
support from AAPS members and officers, and AAPS’s administrative paperwork! Then after the kickoff there are
the operations of the focus group,National
steering committee
and APA teleconference
Biotechnology
Conference meetings, messaging to the members,
triaging program idea submissions for the NBC and AM conferences, and running group meetings for years to
produce whitepapers.
6
Tuesday May 22, 2012 6:45 pm - 8:45 pm
AAPS Therapeutic Protein Immunogenicity
Focus Group (TPIFG)
BIOTEC Section Leadership
Committee
cont.
So who wants to do this, and why bother? It’s not like we don’t already have day jobs to deal with, so where’s the
time? The reason is plain and simple: the advancement of applied science and medicine. As individual scientists I
am certain we
all2012
strive daily
to add value
to our
respective
organizations;
but don’t weat
also
questions and
The
leadership
of the
BIOTEC
section
was confirmed
thehave
2011
scientific gaps
that remain
they may beDC.
out of
scope
at our organizations,
to which we just
Annual
AAPSunaddressed
meeting because
in Washington
The
section
officers andorthe
aren’t able to
devote the time or are
resources?
might be areas where we lack sufficient expertise or experience
representatives
listedThere
below.
that we might enrich by interacting with our counterparts and others across scientific disciplines. So do we limit
ourselves from advancing
Title our fields of science? Or shall we instead embrace
Name a mentality of disregarding perceived
barriers, competitive intentions and, irrespective of our affiliations, be life scientists driven by our common purpose
of providing
better
my friends, is the motivation to be a part
Past
Chairmedicines for humankind through better science?
Mary That,
Cromwell
of a cross-organizational
team and to participate actively in professional
organizations such as AAPS. Whether it is
Chair
Binodh DeSilva
2012 AAPS Committee Representatives
by starting a much needed focus group, contributing to the scientific discussions of Action Program Areas and
Chair Elect
William Nowatzke
Committees, or enabling these groups via your administrative skills, you would enable the advancement of applied
Vice Chair
Tapan Das
science and medicine.
Secretary/ Treasurer
Meena Subramanyam
The power of partnership, collaboration, and volunteerism simply cannot be overstated; in fact, these are the main
drivers for the success of the various focus groups, including TPIFG, the sections, and AAPS overall. And guess
2012 AAPS Committee Representatives
what? It’s also great for your own professional development and visibility! You see where I am going with this – I
am encouraging you to participate in TPIFG and/or other focus groups at AAPS. Recall when you got into your
graduate school, your pos-doc, or when you started your first job, and you had dreamed to change the world
someday through your contributions? Well, now’s the time, and TPIFG is the place. If you would like to get
involved, please contact me or Dr. Quarmby through our TPIFG website,
http://www.aaps.org/Therapeutic_Protein_Immunogenicity/
I wish you a fabulous summer of fun with your families and continued success at your workplace. And TPIFG
hopes to hear from you soon.
7
AAPS TPIFG Team
Therapeutic Protein Immunogenicity Focus Group (TPIFG)
The TPIFG focuses on the immunogenicity of therapeutic proteins- from the enhancement of our basic
understanding of the underlying cause-effect relationships to the development of potential immunogenicity
mitigation strategies to the harmonization of clinical immunogenicity analyses and reporting. The goals and
activities of the TPIFG are established and guided by the TPIFG Steering Committee, while the activities are carried
out within 5 Action Program Areas, each sponsored by a Steering Committee member.
The Steering Committee consists of:
1. Chair: Gopi Shankar, Janssen R&D / Johnson & Johnson, PA
2. Vice Chair: Valerie Quarmby, Genentech, CA [Chair, Oct. 2012-14]
3. Past Chair: Bonita Rup, Pfizer, MA
4. Susan Richards, Genzyme, MA [Chair-elect (Vice Chair), Oct. 2012-14]
5. Meena Subramanyam, Biogen Idec, MA
6. Jeff Sailstad, Sailstad and Associates, NC
7. Eric Wakshull, Genentech, CA
8. Student Representatives: Tarik Khan, (The University of Texas, TX) and Suprita Tawde, (Mercer University,
GA)
Ad Hoc Members: Amy Rosenberg (FDA), Daniela Verthelyi, (FDA), Susan Kirshner, (FDA) and Arno
Kromminga, (European Immunogenicity Platform)
Here is a brief overview of the TPIFG Action Program Areas (APAs):
1. Uniform Reporting of Immunogenicity (Sponsored by Gopi Shankar)
This APA aims to define key terminology, develop recommendations on key aspects of product immunogenicity
and to establish a harmonized approach to biotherapeutic drug immunogenicity data interpretation. This APA
comprises 10 representatives from industry, U.S. FDA, and Health Canada, who’ve produced a draft definitions
paper, including data analysis and presentation approaches. Feedback from the European Immunogenicity Platform
(meeting in Copenhagen, Feb 2012) was taken into consideration and also shared with the ABIRISK consortium (an
IMI section) for incorporation into their work. At the recent NBC meeting (May 2012, San Diego) a round table
session was conducted to obtain feedback from AAPS members. Our goal is to submit a white paper by early 2013.
2. Immunogenicity Prediction (Sponsored by Bonnie Rup)
This APA focuses on the mission of understanding immunogenicity risk factors and advancing the science of
8
AAPS TPIFG Team
cont.
immunogenicity prediction. To advance that mission, the group has formed sub teams to focus on 4 specific risk
factors (Foreign Sequence Risk, Pre-existing Antibodies Risk, Subcutaneous Route of Administration Risk,
Aggregates and Formulation Risk). This APA organized several sessions at 2012 NBC, (Symposium on
Immunogenicity Risk, module on Immunogenicity Prediction for Advanced Immunogenicity Training Session,
Open Forum), conducted 2 surveys (use of immunogenicity prediction tools, pre-existing antibodies) and
developed awareness of the problem of unwanted immunogenicity and opportunities for collaboration with basic
immunology scientists by organizing a Guest Symposium during the American Association of Immunologists (AAI)
2012 Annual Meeting (Immunogenicity of Biotherapeutics: Risk Prediction and Mitigation). The APA works on
collaborative sharing and generation of data on predictive approaches along with facilitating the communication of
regulatory agency expectations in these regards.
3.
Immune Mitigation (Sponsored by Sue Richards)
This APA promotes membership education and involvement in understanding the need for immune mitigation and
development of clinical regimens to mitigate immune responses to biotherapeutics. It is organized into working
groups on each of three topics - Preclinical Immune Mitigation, Clinical Immune Tolerance Induction, Risk Factors
and Biomarkers. The APA also contributed to the Guest Society symposium at the American Association of
Immunologists National Meeting.
4.
Communication (Sponsored by Meena Subramanyam)
Co-lead by Persymphonie Miller (Janssen R&D, Johnson & Johnson, PA) and Suprita Tawde (Mercer University,
GA), this APA keeps the TPIFG membership informed of updates and activities. They are involved in publishing
newsletters as the primary source of information for the TPIFG membership and the broader AAPS readership with
regards to advances in the field of immunogenicity facilitated through the efforts of the TPIFG. The newsletter
highlights proposals submitted to the AAPS National and NBC meetings under the sponsorship of the TPIFG.
5. Programming (Sponsored by Jeff Sailstad)
This APA is involved in proposing programming ideas for AAPS and NBC. It was involved in various 2012 NBC
presentations such as Immunogenicity Training Course II, AAPS Workshop on Clinical Pharmacology and ADME
of Biotherapeutic Proteins, Session: Immunogenicity Risk Assessment, Monitoring and Reporting, Symposia:
Immunogenicity Risk, Characterization of Clinical Immunogenicity, and Biotech Open Forum: Improving
Immunogenicity Risk Prediction and Management.
9
Scientists’ Contributions
Technique-Review
Protein Profiling on Nitrocellulose-Coated Slides: A Novel Biomarker Screening
and Validation Tool for Cell Isolates and Hair Follicles
Rocco J Rotello, Ph.D.
Associate Professor, Pharmaceutical Science Department, School of Pharmacy,
Cedarville University, Ohio. ([email protected])
In the area of biomarker identification, complementary protein detection methods add value if the method preserves
morphology, provides localization and lends itself to determining levels of protein expression. In addition, simple
and reproducible methods of tissue handling and protein immobilization as well as antibody probing and biomarker
characterization are needed that take advantage of sophisticated imaging and scanning technologies, such as the
Typhoon scanner (GE Life Sciences). Isolated or plucked hair follicles are difficult samples to handle because of
their inherent qualities and limited chances to obtain multiple “protein captures” from one sample. Manipulating
isolated hair follicles, which are highly charged and repulsive, is tedious and time consuming, and evaluating
protein expression in the “meat” of the follicle plug with traditional immunohistochemistry and label-retaining
methods is somewhat difficult (1-3). In addition, it is time consuming and laborious to fix, embed and section hair
follicles and surrounding cells in a standard media, such as paraffin and OCT embedding media for frozen sections.
Furthermore, collecting sample sizes to run various assays including standard western blots, semi-dry blotting
methods and diffusion blotting is difficult because of a lack of efficient solubilization and the low levels of protein
per individual follicle. Finally, one needs to be skilled in the pathology of tissue processing and sectioning to obtain
quality slices through respective samples. Various layered membrane approaches and diffusion methods have been
used with varying degrees of success; however, reproducibility and sensitivity with different membranes still remain
as hurdles and may be more useful with specific samples without the hair difficulties (4, 5).
To this end, a simplified method was pursued that preserved hair follicle integrity and morphology, while increasing
sample size analysis per subject and allowed protein localization and profiling, with regards to specific classes of
proteins. In early pilot experiments, the following was demonstrated: freshly pulled and intact hair follicles could
be fixed and preserved in a cold organic solvent, placed in a standard protein transfer buffer similar to what is used
in western blotting. Around 10-20 follicles could be sandwiched between two proprietary 3-D nitrocellulose coated
slides (FAST Slides, Whatman) and incubated at 10-15 minute intervals at 40 °C, without modifications to the
10
Scientists’ Contributions
Technique-Review cont.
incubation chamber or buffer conditions and minimal weight (6 microscope slides) placed on top of the sandwich
assisted in the transfer process. Secondly, the transferred proteins could be probed on the nitrocellulose coated
slides with antibodies and protein levels could be probed separately with EZ-link protein labeling kits and Cy-5
labeled streptavidin. Initial images were collected with a standard slide-based microarray scanner (Figure 1, hair
plugs).
With these nitrocellulose polymer coated slides, protein molecules are bound non-covalently and
irreversibly and antigen concentrations of 1 pg/ml or lower can be detected depending on the signal amplification of
detection. The benefits of the newly described method include ease of sample handling, sample numbers/subject,
multiple blots (12 slide sets for a selected group of follicles), and protein localization. In addition, one avoids
handling gels which can shrink over time and long blotting times used in diffusion blotting methods. The simplified
sample handling, washing and blocking steps and lack of an electrically driven protein transfer eliminate the need to
transfer at cooled temperatures and/or limited transfer times. In addition, reproducible image scans and quantitative
fluorescent data collection per follicle can be achieved. Further refinements and validation in the protein profiling
assay include protein transfer efficiency at multiple time points, differences in transfer of low molecular mass
proteins versus high molecular weight proteins, and probing with various primary and secondary antibodies with
unique fluorochromes.
Figure 1. Photograph on left (A) depicts selected human hair follicles blotted on a
nitrocellulose coated slide (Whatman) which was the top slide of the sandwich and probed
with a pan-actin primary antibody and Cy3 goat anti-mouse secondary antibody; (B) The
bottom slide of the sandwich showing respective follicles labeled with EZ-link biotin
(Pierce) and probed with streptavidin Cy5 dye, which represents protein levels. The
prominent fluorescent region of each image is the “meat” (bulb or matrix) of the follicle,
while no detectable label can been seen in the hair fiber (shaft) which would be to the right
of the stained region. Images were collected using a GenePix 4000B microarray scanner,
with wavelengths set at 532 and 635.
Initial scan results and data collection on the GenePix 4000B microarray scanner were robust in image quality but
limited in data analysis due to the variability in setting up parameters around the pulled hair follicle bulge region
which had different levels of fluorescence intensity. However, qualitative images and regional expression of
proteins in the bulge region of the follicle could be obtained. The software algorithms used in GenePix microarray
scanners were designed to scan individual microarray dots (circular) and defined regions for gene expression
studies. However, with the introduction of the newer technologies such as the Typhoon laser scanner and the
Dyversity imaging system, scans could be obtained with more sensitivity and linearity of results from experiment to
11
Scientists’ Contributions
Technique-Review
cont.
experiment. Typhoon and Dyversity also appear to have image collection and data analysis capability that assesses
levels of protein fluorescence detected via antibody labeling or direct labeling after transferring to the nitrocellulosecoated slide, more accurately and reproducibly. Ongoing method optimization and validation in the nitrocellulosecoated slide assay include positive controls, background fluorescence, levels of fluorescent dyes per reagent and
refinements in the quantitation of protein levels from sequential blots and the implementation of the Typhoon
scanner to accurately assess antibody staining levels/total protein using its software and data analysis parameters.
In conclusion, the described method complements other technologies and methods that are not amenable to
morphological preservation and protein localization, such as mass spectrometry and protein isolation through tape
strip methods (D-squame) which involves physical force, solubilization and quantitation of extracted proteins using
ELISA-based or gel electrophoresis methods (6). The latter technology is appropriate for superficial skin layer
proteins and molecules. The established bi-layered blotting system provides a simple and novel way to do protein
profiling with peculiar samples and is meant to complement other protein-based methods. The ability to obtain
multiple nitrocellulose blots (up to 12 so far) from one set of follicles is promising and it avoids embedding and
sectioning individual follicles in one block which would be similar to obtaining multiple tissue sections from one
embedded piece of tissue or cell isolate. The nitrocellulose coated slides are commercially available and provide a
reliable and uniform blotting surface with almost no bubbles and avoid using low affinity layered membranes and
longer incubation times, with extended blocking and labeling steps.
References:
1.
Consulting editors, Tatsuji Kobori and William Montagna. Proceedings of the First International Symposium on Biology
and Disease of the Hair, Tokyo, Japan, October 6-9, 1975.
2.
Cotsarelis G, Sun TT and Lavker RM. Label-retaining cells reside in the bulge area of pilosebaceous unit: Implications for
follicular stem cells, hair cycle and skin carcinogenesis. Cell 61:1329-1337, 1990.
3.
Camidge DR, et. al. Plucked human hair as a tissue in which to assess pharmacodynamic end points during drug
development studies. British Journal of Cancer May 2005, 92(10):1837-1841.
4.
Gallya Gannot, et. al. Layered Peptide Array for Multiplex Immunohistochemistry, Journal of Molecular Diagnostics, Vol.
9, No. 3 July 2007.
5.
Traicoff JL, et. al. Novel Application of Layered Expression Scanning for Proteomic Profiling of Plucked Hair Follicles.
Dermatology 2005; 210:273-278.
6.
Hendrix SW, et. al. Optimization of the skin multiple analyte profile bioanalytical method for determination of skin
biomarkers from D-Squame tape samples. Skin Research and Technology 2007; 13:330-342.
12
Scientists’ Contributions
Mini-Review
Controlling the Adverse Effects of Anti-Drug Antibodies
Alexandra Joseph and Sue Richards on behalf of the TPIFG Immune Mitigation APA
As the number of biologics that reaches licensure continues to increase, so does our collective understanding of the
development of immune responses to these drugs and their potential clinical impact. Immune responses to biologics
are generally monitored by detection and characterization of anti-drug antibodies (ADA) and assessing ADA
associations with drug exposure, efficacy, and safety. The detection of ADA does not necessarily indicate there will
be clinical consequences. However, there are also an increasing number of examples where ADA can directly
influence drug pharmacokinetics and pharmacodynamics, thereby influencing product efficacy. The development of
ADA has the potential to influence various in vivo mechanisms due to the nature of immunoglobulin biology.
Certain antibodies bound to antigen could activate complement, cause mast cell degranulation, become cytolytic or
form lattices that develop into immune complexes (1-3). The resulting immune complexes are either cleared from
circulation or potentially deposited into tissues. For drugs that are chronically administered, such as adalimumab for
rheumatoid arthritis, there may be long-term consequences of ADA which can include higher disease activity scores
over time in ADA-positive patients and a higher rate of treatment discontinuation due to treatment failure (4). Our
understanding of ADA effects is evolving as more longitudinal data are obtained with biologics. Thus far, clinical
experience has demonstrated unwanted side-effects with a number of biologics (5). Several approaches are now
being used during the preclinical and clinical phases of drug development to minimize ADA responses. Case
studies, primarily for monoclonal therapeutics, are reported where successful drug candidates are identified using
rational drug design strategies. This approach however may not always be possible, particularly with complex
glycoproteins (6), indicating that further investigation aimed at mitigating ADA is warranted.
Expanding interest in approaches for controlling ADA
A cursory review of the literature demonstrates that a number of approaches for reducing ADA are being explored
in both the non-clinical and clinical setting. The studies span from looking at approved immunomodulating drugs
and using them in novel ways to research assessing new investigational drugs. For example, combination of
cyclosporine A with azathioprine has shown promise in inducing immune tolerance to recombinant human alpha-Liduronidase (7). A non-depleting anti-CD4 antibody can reduce antibody responses to equine Ig in primates (8).
Gene therapy has demonstrated immune tolerance induction in non-clinical studies by providing liver-specific drug
expression (9-10). Moreover, ethylenecarbodiimide-fixation can induce tolerance in a variety of non-clinical
settings and is currently being investigated in patients (11-13). In addition, oral tolerance has been broadly
13
Scientists’ Contributions
Mini-Review
cont.
investigated both non-clinically as well as clinically and our understanding continues to evolve in this area (14).
Successful immune tolerance induction coupled with an improvement of drug efficacy has been reported with a
combined treatment of a low-dose induction regimen of methotrexate along with Rituximab and optional IVIG in
treatment-naïve infantile-onset Pompe patients that experience poor clinical outcomes linked with ADA to the
enzyme-replacement therapy, Myozyme (15-16). Additional non-clinical studies suggest that a short induction
treatment of low-dose methotrexate alone can induce immune tolerance to a number of proteins in both normal and
disease settings (17-18).
Understanding Potential Mechanisms of immune tolerance induction
Stimulating research is ongoing into the mechanisms behind these tolerance-inducing methods that minimize the
development of ADAs. As antibody responses are generated predominantly via T cell- dependent B cell activation,
followed by proliferation and differentiation of B cells into antibody-secreting plasma cells, approaches aimed at
controlling ADA often target either T cells, B cells or proliferating cells in general. For instance cyclosporin A
inhibits T cell activation and Rituximab depletes B cells. Additional methods of controlling immune responses
involve the induction of regulatory cell populations such as regulatory T cells and regulatory B cells which have
been associated with immunomodulation (19-20). Azathioprine along with methotrexate kills proliferating cells.
Unexpectedly, in the context of immune tolerance induction however, methotrexate-induced cell depletion is
generally not observed (18) and early data suggest that methotrexate may be inducing regulatory B cells that appear
to reduce ADA.
In conclusion, our understanding of the immunogenicity-related effects of biologics is rapidly evolving. An
increasing body of data indicates that patients would benefit significantly from regimens that can successfully
mitigate the risks associated with ADA. Clearly more work is needed in this exciting area of research.
References
1.
Turley, D.M. et al., 2010. J. Immunol. 178:2212-2220.
11. Boothpur et al., 2010. Am. J. Kidney Dis. 55: 141–143.
2.
Luo X., et al., 2008. PNAS 105:14527-14532.
12. Hunley et al., 2004. Pediactrics. 114, e532.
3.
Getts, D.R., et al., 2011. J Immunol. 187:doi:10.4049.
13. Chung et al., 2008. N. Engl. J. Med. 358:11, 1109-17.
4.
Weiner, H.L, et al., 2011. Immunol Rev.241:241-259.
14. Bartelds, G.,et al., 2011. JAMA. 305: 1460-1468.
5.
Messinger, Y. H., et al., 2012. Genet. Med. 14: 135–142.
15. Giezen, T.J., et al., 2008. JAMA. 300: 1887-1896.
6.
Mendelsohn, N. J., et al., 2009. N. Engl. J.Med. 360: 194–195.
16. Zheng, K., et al., 2011. MAbs. 3: 568-576.
7.
Joseph, A., et al., 2012. J. Immunol. 189, doi:10.4049.
17. Dickson, P., et al., 2008. Clin. Invest. 118: 2868.
8.
Joseph, A., et al., 2008. Clin. and Exp. Immunol. 152: 138-146.
18. Winsor-Hines, D., et.al., 2004. J. Immunol. 173:4715-4723.
9.
Riley, J.L., et al., 2009. Immunity. 30:656-665.
19. Koeberl, D.D. et al., 2009. Curr. Gene Ther. 9: 503-510.
10. Iwata, Y., et al., 2011. Blood. 117:530-541.
20. Sun, B., et al., 2010. Mol. Ther. 18:353-360.
TPIFG Immune Mitigation APA members: Bing Kuang, Claire Holland, Dharmesh Desai, James Herron, Laura Hong, Proveen Dass, Renuka Pillutla, Sofie
Pattijn, Tarik Khan, Alexandra Joseph and Sue Richards
14
Scientists’ Contributions
AAPS Sterile Products Focus Group
The Biotech section would like to highlight the Sterile Products Focus Group (SPFG) in this issue. The Sterile
Products focus group (SPFG) provides a platform to discuss the science and technology of parenteral products that
covers a range of therapeutic entities from small molecules to large biologics. With biologics projected to account
for ~60 percent of total pharmaceutical sales growth, the shift in industry focus on biotechnology products in recent
years has triggered a renewed interest in sterile products. The field of sterile products encompasses progress and
challenges well beyond the basic solubility and stability issues. This focus group is affiliated with the AAPS
Biotech, Formulation and Drug Delivery (FDD) and Manufacturing Science and Engineering (MSE) sections.
The SPFG steering committee is comprised of a diverse group of individuals from the Human Health industry,
Animal Health industry, Emerging Markets and the Health Agency. The committee members for 2012 are:
1. Chair: Vinay Radhakrishnan (Pfizer, Inc.), SPFG representative on the MSE Section
2. Past chair: Qiang Ye (Otonomy, Inc.), SPFG representative on the FDD Section
3. Aniket Badkar, (Pfizer, Inc., Animal Health), SPFG representative on the BIOTEC Section
4. Bakul Bhatnagar (Pfizer, Inc.),
5. Himanshu Bhattacharjee (Merck & Co.),
6. Parag Kolhe (Pfizer, Inc.) SPFG representative on the FDD Section
7. Pankaj Paranjpe (Bristol-Myers Squibb),
8. Mrinal Shah (InnoPharma, Inc.),
9. Manoj Sharma (Merck & Co.),
10. Raman Srinivasan (Biocon, India),
11. Scott Steffen (FDA).
The SPFG has taken several initiatives to discuss and address topics relevant to parenteral products. These include
organizing symposia and sessions at several AAPS annual, national biotechnology and other meetings, promoting
joint programs with other focus groups and societies and organizing webinars pertaining to sterile product
development. The major accomplishments of the SPFG for 2011 and 2012 are listed below:
 Symposia and Sessions:
 (NBC 2012)

New Challenges in Development of Biologics: “Developability Assessment of Protein Drug
Candidates”
15
Scientists’ Contributions
AAPS Sterile Products Focus Group
cont.

Predicting Stability for Biotherapeutics and its Utility for Supply Chain in Third World Countries

Diversity and Complexity of Vaccine Manufacturing: Scale Up and Tech Transfer Challenges and
Strategies

New Challenges in Development of Biologics: Pharmaceutical Development of Antibody-Drug
Conjugates

High Concentration Protein Manufacturing and Delivery: Addressing the Challenges Faced by Biotech
Industry
 (AAPS 2011)


Recent Advances in Non-invasive Drug Delivery of Biopharmaceuticals

Development of Drug-drug Combination Products via 505(B) (2) Approach

Recent Advances in Non-invasive Drug Delivery of Biopharmaceuticals
Conferences: (46th) Arden Conference in West Point, New York (March 2011) and the Asian Arden
Conference in Seoul, Korea (June, 2011)
 Webinar: (2011) “Pharmaceutical Microbiology for Sterile Drug Product Manufacture”
 Publications: SPFG partnered with the AAPS PharmSci Tech Journal to launch a series of themed articles on
sterile products titled “Sterile Products: Advances and Challenges in Formulation, Manufacturing, Devices and
Regulatory Aspects”. To date 20 of 34 manuscripts submitted have been published online. Recently the group
also partnered with AAPS and Springer to publish a book as a part of the AAPS Advances in Pharmaceutical
Sciences series which is expected to launch in late 2012. The book is tentatively titled “Advances in Sterile
Product Development” and will cover various challenges faced by industry around sterile product formulation,
aseptic processing, facility design, delivery and devices for sterile product and regulatory/quality aspects.
If you would like to be a part of the SPFG, please contact me or visit our website,
https://www.aaps.org/Sterile_Products/
- Dr. Aniket Badkar, Pfizer, Inc.
([email protected])
SPFG representative on the BIOTEC Section
16
Students’ Corner
TPIFG Student Education
Why is immunogenicity towards therapeutic proteins important?
Unwanted immunogenicity can lead to many clinical consequences in safety and efficacy.
Therapeutic proteins are capable of stimulating the adaptive immune system to generate
anti-drug antibodies (ADAs). Negative consequences can be manifested through ADAs
by neutralizing the therapeutic agent, reducing its circulation half-life, inducing
hypersensitivity, etc. In the case of replacement therapies, immunogenicity can lead to a
Dr. Tarik Khan
worsening of the disease state by ADAs targeting endogenous protein.
What factors cause therapeutic proteins to be immunogenic?
The extent and type of immune responses are related to many different intrinsic and extrinsic drivers. Some of the
factors believed to contribute to immunogenicity are summarized below:
Intrinsic Issues
Extrinsic Factors
Product/Process

Molecular variations (e.g. amino acid sequence,
glycosylation pattern, etc)

Process related impurities that co-purify with the
product (e.g. metals, glass, plastics, etc)

Host Cell Proteins

Aggregates (% of formulation, size distribution, etc)
Patient
 Disease status
 Immune status
 Genetic background
 Concomitant medication
Formulation/Storage

Degradation

Conformational changes

Aggregation
Dose

Dose level

Dose frequency

Intermittent dosing
Route of administration

SC or ID >IM>IV
What can be done about immunogenicity?
There is a need for standardized reporting of immunogenicity in order to compare data. These standardizations
must be made in both the analytical techniques employed to study clinical samples as well as the monitoring
process of patients receiving biologic therapeutics. There is also a strong need to develop predictive tools that can
determine clinical immunogenicity, which at this time is believed to be extremely variable. Using prediction tools,
17
Students’ Corner
TPIFG Student Education
cont.
the immunogenicity of therapeutic proteins can be mitigated by reducing drivers of immunogenicity as well as
introducing mechanisms to induce tolerance.
As a student why should I care about immunogenicity?
Immunogenicity to therapeutic proteins is a problem that will not be solved overnight. There will continue to be
many opportunities for students to work in the field of immunogenicity. In order to reduce immunogenicity there is
a need for scientists that understand serum bioanalysis, formulation characterization, and mechanistic immunology.
These skills will be highly valuable to industry for many years to come.
Mark Your Calendar!
What
2nd Mastering Immunogenicity
8th Annual Bioassays and Bioanalytical Method
Development
Fourth Annual Immunogenicity Summit
2012
2012 AAPS Annual Meeting and Exposition
16th Annual Well Characterized Biologicals conferences
Virus-like particles & Nano-particle Vaccines
Biotech Showcase 2013
Peptalk
Fifth Annual Protein Purification & Recovery
When
Sept 17-18, 2012
Oct 1-3,
2012
Oct10-12, 2012
Where
Boston, MA
Berkeley, CA
Oct 14-18, 2012
Oct 30- Nov 01, 2012
Nov 28-30, 2012
Jan 07-09, 2013
Jan 21-25, 2013
Jan 21-22, 2013
Chicago, IL
Washington, DC
Cannes, France
San Francisco, CA
Palm Springs, CA
Palm Springs, CA
Antibodies for the 21st Century
Jan 23-24, 2013
Palm Springs, CA
Bio-inspired Systems and Signal Processing
Feb 11-14, 2013
Barcelona, Spain
Analytical Technologies for Biotherapeutic Development
Feb 27 – Mar 01, 2013
Understanding Dendritic Cell Biology to Advance Disease
Therapies
Bioassays 2013
Mar 03-08, 2013
Huntington Beach,
CA
Silverthorne, CO
Mar 04-05, 2013
Rockville, MD
3rd Annual International Conference on Advances in
Biotechnology
2013 Annual Meeting: Regulation & Dysregulation of
Immunity
The American Association of Immunologists Annual
Meeting
AAPS National Biotechnology Conference
Mar 18-19, 2013
Apr 25-28, 2013
Canning Walk,
Singapore
Miami, FL
May 3-7, 2013
Honolulu, Hawaii
May 20-22, 2013
San Diego, CA
Bethesda, MD
- Compiled by
Trinh Vo, Ph.D. Student, Mercer University, Atlanta
18
Students’ Corner
Technique-Review
Proteins and Tangential Flow Filtration
Tangential flow filtration is a commonly used technique in the biotechnology
industry for protein concentration and buffer exchange. As in normal flow
filtration, the fluid flows at an angle “normal” to the filter membrane; in
tangential flow filtration (TFF), the flow of fluid is at a “tangent” to the
membrane surface. Normal flow filtration is associated with large protein
Lipika Chablani
Ph.D. Candidate
Mercer University, Atlanta
[email protected]
molecules blocking the membrane; here TFF offers the advantage of
sweeping off these large molecules due to the tangential flow. TFF is also
referred to as cross-flow filtration. TFF is further categorized into
microfiltration, ultrafiltration, nanofiltration and diafiltration depending upon the membrane pore size cut-off range
or nominal molecular weight limits (NMWL).
 Microfiltration (MF) employs the use of a micron size (0.05-10m) membrane filter to primarily sterilize or to
yield a particle-free protein solution. Microfiltration retains intact cells and cell debris while allowing colloidal
material, viruses, proteins and salts to pass through the membrane.
 Ultrafiltration (UF) is the most extensively used form of TFF. It is used as a technique of choice over size
exclusion for protein concentration and buffer exchange. UF utilizes membrane NMWLs in the range of 11000kD depending upon the protein being concentrated. UF is further classified into two categories-Virus
filtration and high performance tangential flow filtration (HPTFF). Virus filtration is used to separate virus-like
particles from the protein when protein is produced via mammalian cell cultures, which either contain endogenous
virus-like particles or are prone to viral contamination. This process retains viruses/virus-like particles above a
membrane of 100kD-0.05m pore size and filters the proteins and salts. HPTFF on the other hand is capable of
protein-protein separation on the basis of both size and charge (a charged membrane is used for this purpose). It
can not only separate protein monomers from the dimers but can also provide protein purification, concentration
and buffer exchange in a single unit operation. The molecular weight cut-off for this type of filtration ranges from
10-300kD.
 Nanofiltration uses a membrane of less than 1kD pore size to filter salts and small molecules and retain
water/solvent molecules. This technique has been used for water purification in conjunction with reverse osmosis.
 Diafiltration is a TFF process performed to improve the purity or yield of any of the above filtration processes.
19
Students’ Corner
Technique-Review
cont.
As the filtered components are removed after the TFF, fresh buffer is introduced into the protein slurry, which
passes through the membrane at the same rate as the filtrate is being removed, maintaining constant volume (also
known as constant volume mode). Buffer assists in washing off the protein from the membrane into the retentate if
the desired protein is of higher molecular weight than the membrane cut-off. Also, buffer is useful in washing the
desired protein species into the filtrate through the membrane if the product lies in the filtrate. Diafiltration can also
be performed in batch mode, where a large volume of the buffer is introduced to concentrate the protein in the
retentate as buffer washes off the unwanted species into the filtrate.
Overall, TFF offers a variety of options to concentrate, purify and separate proteins on the commercial scale.
References:
1. van Reis, R. and A. Zydney, Membrane separations in biotechnology. Curr Opin Biotechnol, 2001. 12(2): p. 208-11.
2 Millipore, Protein Concentration and Diafiltration by Tangential Flow Filtration. Accessed on June 20th, 2012 at:
http://www.millipore.com/publications.nsf/a73664f9f981af8c852569b9005b4eee/ab3ba3a9d06cc6f185256bd10068b0de/$file/t
b032.pdf
Biologics Approvals by US-FDA in 2012
Trade name/ proper name
Indication
Manufacturer
Avioq HTLV-I/II Microelisa
Detection of antibodies to Human T-Lymphotropic Virus Type I (HTLV-I)
Avioq, Inc., Research
system
and/or Type II (HTLV-II) in human serum or plasma, for screening organ
Triangle, NC
donors.
GINTUIT
It is intended for topical (non-submerged) application to a surgically created
Organogenesis, Inc.
Allogeneic cultured keratinocytes
vascular wound bed in the treatment of mucogingival conditions in adults.
MA
and fibroblasts in bovine collagen
Biologics Recalls by US-FDA in 2012
Trade name / Proper name
Reason for recall
Manufacturer
GAMMAGARD LIQUID
As a precautionary measure as there was an error in printing the carton and
Baxter Healthcare
(Immune Globulin Intravenous
product vials with incorrect manufacturing and expiry date
Corporation, Westlake
(Human) 10% solution)
Village, CA
M-M-R® II (Measles, Mumps,
Merck is voluntarily recalling M-M-R® II due to the inadvertent shipment
and Rubella Virus Vaccine Live)
of doses from the lot to US customers.
Merck & Co., Inc.
Prevnar 13 (Pneumococcal 13-
Voluntary recall for the lot was formulated and filled with expired serotype 3
Pfizer
valent Conjugate Vaccine)
conjugate material.
New York, New York
Compiled by
Archana Akalkotkar, Ph.D. Candidate, Mercer University, Atlanta
20
Students’ Corner
NBC 2012 Highlights
NBC 2012 Sunrise Session:
“Diversity and Complexity of Vaccine Manufacturing:
Scale Up and Tech Transfer Challenges and Strategies”
Nisha Nanaware-Kharade, University of Arkansas for Medical Sciences
Student moderator ([email protected])
Vaccines are one of the best and most common cost-effective tools for disease prevention and control.
However, there is an ongoing struggle to improve safety and potency, increase tolerability, prevent shortages,
reduce cost, and introduce new vaccines into the market. The application of more efficient and technologically
advanced manufacturing processes has helped to overcome some of these hurdles. Dr. Parag Kolhe from Pfizer Inc.
organized a sunrise session at NBC 2012 for the FDD section focusing on challenges in vaccine manufacturing
such as defining the right process, scale up, technology transfer approaches, potential degradation of antigen etc.
The session had two excellent speakers: 1) Dr. David Volkin, a distinguished Professor of Pharmaceutical
Chemistry and Co-director of the Macromolecular and Vaccine Stabilization Center at the University of Kansas and
2) Dr. Sandipan Sinha, a Principal Scientist in the Department of Formulation and Process Development at Pfizer
Inc.
Dr. Volkin set the stage for the session by reviewing various aspects of different types of vaccines
including live, attenuated, inactivated organisms, recombinant proteins, conjugated, virus like particles, gene based
vaccines, novel adjuvants and vaccine delivery systems. He also discussed the use of variable path length UV–Vis
absorption spectroscopy for studying protein–protein interactions, especially in high-concentration solutions. Dr.
Sinha addressed issues related to multiple components of conjugated vaccines that increase the complexity of
manufacturing operations and stability. He discussed biophysical approaches to formulation and stabilization of
vaccines pertinent to freeze-drying and reconstitution. He further described how external conditions such as stress
during storage and transport of vials resulted in flocculation and/or aggregation. He emphasized that stability of
vaccines during storage and transport together with the compliance of healthcare professionals with product labels
are critical to ensure their efficacy, potency, and safety. Overall, the sunrise session was well attended and received
positive feedback. I would like to thank Dr. Kolhe, NBC leadership and the Biotech Section Student Committee for
offering me the opportunity to co-moderate this session. It was a great learning and networking experience.
21
Students’ Corner
NBC 2012 Highlights
NBC 2012 Biotech Open Forum
Improving Immunogenicity Risk Prediction and Management
Sujay V. Kharade, Ph.D., University of Arkansas for Medical Sciences,
Attendee ([email protected])
The use of biopharmaceuticals in the treatment of many diseases has become increasingly common during
the last two decades. Advancement in rDNA, hybridoma and computational technology has provided the necessary
tools to design more effective biotherapeutics. However, the risk of developing immune responses is always
associated with their usage. The development of anti-drug antibodies (ADAs) in response to biotherapeutics can
greatly impact their safety (by provoking hypersensitivity reactions) and efficacy (by affecting the PK/PD). Thus, it
is immensely important to be able to predict and manage the immunogenicity risk of the final product in order to
make it more efficacious and safe. The open forum was specifically designed to address all these vital issues that are
linked with the use of biotherapeutics.
Listed below are some of the 12 presentations in the open forum: 1) Introduction to therapeutic proteins
and TPIFG, by Gopi Shankar (Janssen R&D) set the stage for the forum and addressed the efforts by the TPIFG to
increase awareness across the industry 2) Immunogenicity risk and management from regulatory perspective, by
Susan Kirshner (FDA) described how the FDA and companies can work together to solve these issues. 3) Foreign
sequences, by George Gunn (Janssen R&D) provided basic information on immunogenicity induced by
biotherapeutics. 4) Pre-existing antibodies (PEAs), by Alyssa Morimoto (Genentech Inc.) described the importance
of PEAs. 5) Aggregates/formulation and route of administration, by Harald Kropshofer (Roche) discussed how
formulation aspects and routes of administration can influence the type and extent of immune response.
Although this was a paid event the room was full of attendees who themselves were leaders from industry
and academia. All presenters were passionate, engaging and tried to involve the audience. In addition, there were
two breakout sessions to facilitate discussion and interaction. The organizers, speakers and even the attendees were
driven by a single mission to make biotherapeutics more safe and efficacious for patients. Overall, the forum was
well-received, fruitful and prompted the audience to participate in the various shared efforts initiated by the TPIFG.
22
Students’ Corner
Student Co-Moderators/Moderators say…
“As the student-liasion for the NBC, I was thrilled to take an active role in organizing and moderating the “PostGraduation Dilemma” sponsored by the Student/Postdoc Outreach and Development Committee (SPOD) session. I had a
tremendous opportunity to brainstorm with other BIOTEC Section Student Committee (BSSC) members and Biotec
leadership for ideas for the event. I was also able to organize a teleconference with all three speakers and the session
facilitator prior to the conference and to collate the presentation for the session. Being a student moderator is a great
networking opportunity particularly for professional development. The SPOD session provided attendees with valuable
insight on opportunities after graduation from industry, academic and government perspectives. We had a great turnoutapproximately 50 out of the 100 students at the conference attended the event!”
-
Sophia Ononye, The University of Connecticut
“As a graduate student, I have been attending national and international conferences for the past few years and I am always
looking for an opportunity to “face” larger audiences. I believe co-moderating a session is a great start so I volunteered to
do so. Working closely with the moderator of the session, Dr. Xiangyang Wang, I communicated with the speakers before
the conference, obtained their biosketches, introduced them to the audience and made sure the session was proceeding as
scheduled. This session helped me to communicate with senior colleagues, improve my organization and management
skills and face a larger audience. I thank the NBC for giving me the opportunity and hope it continues student comoderation in the coming years!”
-
Lakshmi Prasanna Kolluru, Mercer University, Atlanta
“This year at the NBC, I co-moderated the roundtable session, “Towards a Holisitc and Evolving Approach for
Translational Biomarkers: The Convergence of Analytical, Biological, and Clinical Disciplines” with Dr. Scott Fountain
and Dr. Chi-Hse Teng. I volunteered for this organizational role because I wanted to gain leadership experience, actively
participate in discussions, and learn about a scientific field outside of my thesis work. During the event, I introduced all the
speakers to the audience with short biosketches, helped manage time, and actively contributed to discussions. From this
experience, I gained a broader scientific understanding, strengthened my public speaking skills, and met many new people.
I thought this was a terrific way for students to get involved in the Biotec Section, and I would happily volunteer to
moderate another session in the future.”
-
23
Tracy Ooi, The University of Texas at Austin
Students’ Corner
Student Co-Moderators/Moderators say…
cont.
“My experience was good. I had the opportunity to introduce the speakers and moderate the panel
discussion. Since the session was related to my research interest, it benefitted me scientifically as well.”
-
Prathap Shastri, Mercer University, Atlanta
“Co-moderation of symposia and sessions by students is a great initiative by the AAPS Biotech section that enables students to
participate more actively in the AAPS activities as well as build their leadership skills. I had the opportunity to moderate a
symposium titled, “Formulation and Analytical Characterization of Biosimilar Products: A Balance of Cost and Establishing
Biosimilarity” under the guidance of Dr. Tapan Das. I was especially interested in co-moderating this session as biosimilars is
currently a hot topic in the biotechnology industry and this was a great opportunity for me to learn about the current scenario in
the industry with respect to the formulation, characterization as well as the possible challenges in biosimilar development. This
experience also gave me insight into the management and organization of sessions. I believe that such opportunities give students
a chance to interact and network with scientists from industry which not only helps them to widen their knowledge base but also
establish contacts. Overall, it was a very enriching experience for me and I would definitely encourage other students to make
use of it in the future. “
-
Ruhi Vikram Ubale, Mercer University, Atlanta
AAPS Immunogenicity Education: Challenges and Career Opportunities
The AAPS Therapeutic Protein Immunogenicity Focus Group is presenting a novel program where eminent scientists from industry will visit
local schools to provide an update on immune responses to therapeutic proteins, various challenges in this field and various career
opportunities for young scientists.
Objectives

Provide a platform where scientists from industry can visit local schools

Help students to gain current knowledge of immunogenicity related topics

Inform students of career opportunities in the biopharmaceutical industry

Provide colleges and their faculty access to industry experts for free

Foster sharing of knowledge between academia and industry scientists
Key Player 1: Scientists from Industry
The program involves volunteers who are experienced scientists from various disciplines in industry such as analysis and pharmaceutical
quality, biotechnology, immunology, clinical sciences, pharmaceutics and biologics delivery, pharmacokinetics, pharmacodynamics and
protein metabolism, and preformulation scientists in protein research. The scientists from industry will share their knowledge/research in their
field of expertise with budding scientists as well as discover the research carried out in academia.
Key Player 2: Graduate Schools
Research area: biologics / protein formulations / vaccines / immunology.
For more information please go to this link: AAPS Immunogenicity Education
24
[Tarik Khan and Suprita Tawde]
NBC 2012, San Diego, CA
Binodh DeSilva presenting award to Jean Lee
BIOTEC EC
Networking dinner
Thank you for
your continued support!
[Courtesy: Masood Khan, Philip Oldfield]
25
Awards!
Biotechnology Distinguished Service Award
Jean Lee, Ph.D.
AAPS Innovation in Biotechnology Award
Steven Jay, Ph.D. – Lead Author
Brigham and Women’s Hospital
Mark Spengler, Ph.D. – Lead Author
Chimera Biotec GmbH
Shraddha Thakkar, M.S. – Lead Author
UAMS
Payal Agarwal, Ph.D. – Lead Author
Notre Dame of Maryland University
Sathy V. Balu-Iyer, Ph.D. – Lead Author
University at Buffalo, SUNY
AAPS Excellence in Ligand Binding Assays Award
Jay Wustner – Lead Author
Morphotek
AAPS Biotechnology Graduate Student Symposium Award
Anna Astashkina
University of Utah
Jinpu Yang
New York Medical College
John Rhoden
Massachusetts Institute of Technology
Rinku Baid
University of Colorado Anschutz Medical Campus
Biotechnology Section Travelships
Archana Akalkotkar
Mercer University
Nitin Dixit
University of Connecticut
Sunny Kumar
South Dakota State University
Prathap Nagaraja Shastri
Mercer University
Yan Wang
University of Southern California
[Courtesy: Me’Gesha Portlock]
26
Announcements!
Opportunities for All!
Participants for the Therapeutic Protein Immunogenicity Education Program! (refer page 24)
Participants for Biotec 101: eLearning Series (visit AAPS website)
Opportunities for Students!
The Biotech Section is now looking for:
Student Representatives for Sterile Products Focus Group
Student Representative for Systems Biology Focus Group
Organizer for the Therapeutic Protein Immunogenicity Education Program at your school!
*Please visit the AAPS website for contacting the respective focus group chairs for the above opportunities
(Refer page 5).
Congratulations to New members of Biotech Section Student Committee!
Hardik Mody (the University of Georgia) as Chair-Elect/Vice Chair
Nisha Nanaware (the University of Arkansas for Medical Sciences) as NBC Liaison
Apply for Awards!
(Visit aaps website)
AAPS Travelships: Deadline- July 27, 2012
Global Health Focus Group Travelships: Deadline July 27, 2012
Focus Groups Announcements!
(Events at AAPS 2012)
Global Health Focus Group
2012 Pharmaceuticals in Global Health Focus Group Membership Meeting: Inhalable Measles and HPV Dry
Powder Vaccines for Use in Developing Countries, Presenter: Dr. Robert E. Sievers
Systems Biology Focus Group
2012 PPDM Open Forum: Systems Therapeutics-Attaining Intimate Understanding by Unraveling Complexity
*Please visit the AAPS website for more details
27