July 1, 2010
Althea 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 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 Althea Advantage
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.
About the Author
Author Details
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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