Download Glasgow, UK FACTSHEET

Glasgow, UK
FACTSHEET
Sterile Fill Finish and Formulation Development & Clinical Trials Manufacturing
At Aptuit’s Glasgow facility, specialists in sterile dosage forms deliver
• Analytical and Ancillary Services
liquid and lyophilized formulation development, complemented by
– GMP release testing
GMP sterile manufacturing facilities that include lyophilized and
– GMP product stability
cytotoxic products. Our scientists deliver innovative and quality
– QP release
solutions for Pharmaceutical Sciences programs. The Glasgow site
– QA support and consulting
has been part of the Aptuit family since 2007, when it joined the
– Labeling/packaging and storage/distribution
organization as part of the Evotec acquisition.
Site Activities
The pharmaceutical sciences delivered from the Aptuit
Glasgow facility fall into three key categories:
• Preformulation and Formulation Development,
including analytical development services for
method development, transfer and validation
Why Aptuit?
The fact that Aptuit can deliver both sterile fill/finish services
and formulation development services within the same facility
provides significant benefits to clients. Aptuit can manufacture,
release, package and ship clinical materials in as few as six
weeks. Aptuit’s capabilities in Pharmaceutical Sciences span
– Liquid & lyophilized formulations of small organics,
peptides, proteins and nucleotides
a wide range of dosage forms and delivery systems. Our
– Solubility & stability enhancement
scientists in the industry – are what make this possible. Our
– Proof of concept stability
scientists can deliver quality solutions for your Pharmaceutical
– Assessment of solution stability in infusion system
Sciences program using innovative and flexible solutions.
– Small scale prototype batch manufacturing
capabilities for liquid and lyophilized products
(utilizing the FTS Lyostar II lyophiliser system).
Quality Assurance
• Manufacture of Sterile Products for Clinical Trials
people – some of the most experienced pharmaceutical
The Glasgow site has high standards for quality and regulatory
compliance. The site utilizes a Pharmaceutical Quality Management
– Liquid fill batch (up to 10,000 units) aseptic production; highly
potent and non-cytotoxic compounds for Phase I and II studies
System that meets EU GMP standards. In addition to maintaining a
– Primary packaging (glass vials, ophthalmics, nasal sprays)
regularly audited by clients and inspected by government regulatory
– Liquid & lyophilized filling
agencies; no critical or
– Ability to develop formulations for NCEs through the transfer
of existing manufacturing processes into the Glasgow facility
major findings have been
high standard of internal quality processes and procedures, the site is
cited. Aptuit Glasgow is
licensed for Investigational
Medical Products.
APT/FACT/GLAS/01/14/V004
Glasgow, UK
FACTSHEET
Sterile Fill Finish and Formulation Development & Clinical Trials Manufacturing
Formulation Development Services
Sterile Manufacturing Services
Liquid Formulation
Terminally Sterilized and Aseptic Filling, with or without Freeze Drying
• Formulation Type
• D
edicated Clean Room Suites (Grade D to A) for
highly potent and non-Cytotoxic compounds
– Parenteral
– Oral
– Ophthalmic
– Nebulised
• Solubilization Methods
– pH/organic solvents
– Organized into two units with three clean room suites and
two dedicated lyophilizers for non-cytotoxic and cytotoxic
products. Each unit includes a component preparation
room, holding area for sterilized components, compound
preparation area, and finished product filling/crimping area.
– Cyclodextrins
– Manual (flexible) manufacturing processes
utilizing disposable contact parts
– Surfactants
– Process qualification covers 2 to 100ml vials
– Liposomes/lipids
– Up to 40L maximum batch volume
• S
tability Data Assessment using Arrhenius Model
for predicting drug formulation shelf life
• Sterile Manufacturing Expansions in 2012
• Compounding Process Development
– Upgraded Unit 2 filling suite, with a larger
class II manual filling cabinet
• Sterilization Method (filtration, autoclave)
– Upgraded component preparation areas
• Finished Product Stability
– New automated filling machine, Flexicon FPC 50 with Restricted
Access Barrier System; increases liquid batch size to 10,000 units
and lyo batch size to 6,000 2ml vials and 3,000 10ml vials
Lyophilized Formulation
• T
hermal Properties
of Formulation
– Freeze drying microscopy
– Differential Scanning
Calorimetry (DSC)
• S
election of Lyophilization
Excipients (cryo/lyo
protecting properties)
• D
evelopment of
Lyophilization Cycle
(FTS Lyostar II)
• Optimization of Cycle parameters
– New tray vial washer that aligns vial tray system with auto-filler
recently installed as part of major upgrades and expansion
investment offering continuous Grade A containment for the
primary packaging material through the manufacturing process.
Analytical Services
HPLC Analysis
• Method acquisition for assay and impurity analysis
• HPLC Method Development
– Reverse phase
– Normal phase (including chiral assay development)
– Size exclusion chromatography (molecular weight distribution)
• Assessment of Stability of Reconstituted Solution
• Detection Systems (UV, DAD, RI, ELSD)
• Finished Product Stability
• HPLC Method Validation (full ICH or partial)
APT/FACT/GLAS/01/14/V004
Glasgow, UK
FACTSHEET
Sterile Fill Finish and Formulation Development & Clinical Trials Manufacturing
Analytical Services, continued
Uncommon expertise. Exceptional results.
Protein Analysis
Aptuit provides early to mid-phase drug development solutions by
• Protein assay (standalone UV)
applying scientific excellence, outstanding service and a team of some
• Gel electrophoresis (SDS-PAGE)
of the foremost scientific professionals in the industry. These drug
• Isoelectric focusing (IEF)
discovery and development professionals offer proven experience
• Size exclusion chromatography (molecular weight distribution)
in key therapeutic areas. They share a legacy of success, having
advanced a large number of molecules efficiently, expeditiously and
Other Analysis
economically, from early discovery through clinical development with
• Gas chromatography
low attrition rates.
• Mass spectrometry
It is our uncommon expertise that allows Aptuit to identify the
unexpected, mitigating risks and maximizing promising possibilities,
ensuring exceptional results through an open, transparent climate of
trust that our clients can count on.
Aptuit’s comprehensive drug development services include:
•
•
•
•
•
Drug Design & Discovery
Preclinical Biosciences
API Development & Manufacture
Solid State Chemistry
Pharmaceutical Sciences
• Aptuit INDiGO® - fast track
to IND program
• Integrated Drug Discovery
& Development
For information about Aptuit’s services, please contact us:
in Europe: +39 045 821 9333
in the US: 855-506-6360
email us at: [email protected]
www.aptuit.com
APT/FACT/GLAS/01/14/V004