Scalable cGMP Manufacturing
Althea uses a fully integrated development and manufacturing plan to power your drug program from research concept all the way to filled vial of clinical test material. With a broad range of production scales, outstanding regulatory record, and significant microbial-based manufacturing expertise, we provide a tailored and cost-effective manufacturing solution for each drug substance.
As your program advances in the clinic, Althea provides the capacity and quality 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. Throughout process development and cGMP manufacturing, the Althea cGMP manufacturing team works closely with our protein analytics group to ensure integrity of your drug substance every step of the way.
The cGMP manufacturing team at Althea has highly experienced staff who work closely with our development team ensuring scalability to full cGMP production of bacterial and yeast expression-based drug substances. Our manufacturing facility is fully flexible and scalable with the ability to produce in 30L, 100L and 1,000L fermenters. We utilize well-established protocol-based technology transfers to bring in customer developed processes; alternatively, we can employ the efficient processes developed and/or optimized by our own Althea process development scientists.
Recovery and Purification
Following production by microbial fermentation, Althea will purify your bulk drug substance according to process transfer protocols or methods established during process development. Althea’s purification facilities are equipped with a wide range of validated equipment that accommodate all methods and scales of primary recovery, solubilization with refolding, chromatography and filtration required to support production up to 1,000L scale.
Our highly experienced manufacturing team purifies a wide variety of protein types and customizes the purification methods based on the unique purity requirements specific to each product. The substance is either packaged as purified bulk drug substance or seamlessly transferred to our Fill Finish facilities for final drug product manufacturing.
For additional information about Althea’s cGMP manufacturing, microbial fermentation, or drug substance recovery and purification, please contact us.