Our Biologics Manufacturing Group (BMG) supports clients with cell banking, process development, cGMP manufacturing, and formulation of the API. While our experience and expertise is demonstrated by our track record of >150 cGMP lots of drug substance, we know that the successful production of cGMP product depends upon the fluid integration of process and analytical development, cGMP manufacturing, QC analytics, and product formulation. At Althea, you have all of these groups working hand-in-hand, for you and your product. Throughout process development and cGMP manufacturing, BMG works closely with our protein analytics group to ensure product integrity every step of the way.
In addition to the efficient production of your bulk drug substance, our complementary final drug manufacturing capabilities allow you to leverage the full value and efficiency of Althea’s fully integrated manufacturing program in providing you with finished product in vials or syringes. As your program advances in the clinic, you’ll have the assurance of knowing that Althea has the capacity to scale your process to larger product volume requirements without changing facilities. Leveraging this capacity eliminates the need for redundant technology transfer and qualification of additional service providers. With this fully integrated development and manufacturing plan, we can truly take your program from concept to vial.
PROJECT MANAGEMENT & BUSINESS PROCESS
Working with you from start to finish.
QUALITY & REGULATORY
Taking pride in our history of quality.
Process Implementation Group successfully transferred in a process for expressing an anti-cancer recombinant ribonuclease in E. coli. An engineering run was executed, which included a 100 L fermentation, 1,000 L refold, and 3-column purification. The cGMP campaign was successfully completed with 25 grams of recombinant protein delivered to the client.