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Contract Services and Clinical Trials
Althea Technologies, Inc.
Fully Integrated Manufacturing Solutions for Your Drug Product
A
lthea is a contract developer and manufacturer of
biopharmaceutical and injectable products, with fully
integrated product development and cGMP
manufacturing expertise to support client projects
from preclinical development through commercial supply. Each
project program at Althea is tailored to the specific needs of
your product, allowing you to leverage our entire integrated
manufacturing approach, or just the parts you need. While
realizing all of the tangible benefits of consolidating your
development and manufacturing steps, you’ll also have the
confidence of knowing that your product is being championed
by seasoned professionals that boast an impressive track record
of more than 150 cGMP lots of bulk drug substance and more
than 750 cGMP lots of final product delivered-to-date.
Biologics Manufacturing — Recombinant Protein and
Plasmid: Whether it is protein or plasmid production, Althea’s
experienced staff can take your microbial-expressed product
from cell banking to final formulation. As you advance your
product candidate, Althea’s experienced technical team will be
a champion for your product every step of the way through
clinical development and commercialization.
Protein Analytics — Analytical Program Design and
Product Characterization: A successful biopharmaceutical
product depends on a comprehensive and well-designed
analytical program. Whether it is to support process
development, formulation development, or quality control,
strong analytical capabilities is the key to the advancement of
your biologics product into the clinic and beyond.
Formulation Development — Solution, Lyophilized, and
Alternate Formulations: Althea’s formulation development
capabilities can be applied to proteins, glycoproteins, plasmids,
peptides, vaccines, monoclonal antibodies, and antibody
fragments. At Althea, our formulation development and protein
analytics teams work as a cohesive unit to provide you
integrated and robust product development services.
Aseptic Fill and Finish Manufacturing — Vials, Syringes,
Lyophilization: At Althea, we can provide you with a reliable
supply of final product in vials or prefilled syringes for every
stage of development and commercialization. Being fully
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BioProcess International
scalable allows for streamlined manufacturing throughout
development and reduced expenditures, by avoiding the need
to qualify additional vendors and transfer processes as you
move into commercialization.
As one of the few fully integrated development and
manufacturing service providers in the industry, many of the
steps in your supply chain from drug substance to final product
can be consolidated when you partner with Althea to reduce
the time, cost, and risk associated with moving product across
multiple service providers. Contact us today (www.
ALTHEATECH.com) to discuss how Althea can drive value to
your drug development and manufacturing program.
Innovating for the A lthea A dvantage
Althea is continuously innovating to create advantages that
reduce the time, cost, and risk of biologics manufacturing for
our clients. One such innovation is the deployment of our
Delta V system with the Finesse TrueBio overlay that is used to
control Althea’s 5-L process development (PD) fermentors, as
well as our 100-L and 1000-L GMP manufacturing units. By
developing our fermentation processes with this control
software at the PD scale, we ease the scale-up and transfer of
these process controls to GMP manufacturing. Althea routinely
scales directly from PD to the GMP manufacturing scale while
maintaining yield and product quality, thus reducing the cost
and time required for bulk drug production. As a client of
Althea, we innovate for you. •
Brian Lange is associate director of marketing for Althea
Technologies, Inc., 11040 Roselle Street, San Diego, CA 92121;
1-858-882-0123, toll free 1-888-4ALTHEA; [email protected],
www.altheatech.com.
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