Microbial drug substance manufacture

Our microbial manufacturing scientists are here to help from early phase to commercialization

Our microbial manufacturing professionals are experienced in developing, optimizing and scaling-up microbial fermentation and product purification processes. Technical experts are involved right from the start of the project and remain involved during process transfer and production. This ensures a smooth transition from the project’s early development phase through to commercialization.

Preclinical to early clinical manufacture and late clinical to commercial manufacture

Our pre-clinical to clinical manufacturing services offer non-GMP pilot capabilities and cGMP scales from 70L to 1000L. We have experience with a variety of product types including recombinant proteins, conjugated vaccines, novel scaffolds, new molecular formats, plasmid DNA, and other biopharmaceuticals. Our late clinical to commercial manufacturing services include bioreactors of 1,000, 4,000 and 15,000L. We model your appropriate scale and scale up strategy based on your clinical path, mid and long term product demand and launch and commercialization strategy. Our set of bioreactors provide the ability to launch at a scale that optimizes entry to market with the flexibility to adapt the scale to meet future market demand. We start 3-4 new late stage/BLA/sBLA programs per year; our approach balances different priorities, timelines, risks and provides an overview of the entire program.

Product lifecycle management

We offer solutions for the entire lifecycle of your product from preclinical to commercial stages, from drug substance to drug product. Depending on the needs of your molecule and your program, we can utilize our network and capabilities to offer the appropriate suite of services. The variety of our offerings provides the flexibility of a complete program - from gene to drug product - or the option to transfer in at a later stage depending where you are in your journey.

Specialized Capabilities

We have significant experience with insoluble processes including refold capabilities up to 15,000L scale. Our experience includes isolating, solubilizing and properly re-folding proteins from inclusion bodies. We apply the right approach to insoluble processes that are not only viable at scale but can offer great opportunities for yield improvement versus soluble production.

Our manufacturing facilities are able to accommodate:

• BSL-2 strains in single-use systems
• Molecules with an OEL of < 10µg/m³
• Use of organic solvents depending on the scale