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13th March 2020

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Partnering with a Global Pharmaceutical Company for Large Scale Enzyme Manufacturing

Biocatalysts
A large pharmaceutical company needed an enzyme manufacturing partner to develop their enzymes from lab to commercial scales.

Application
The enzymes are part of a cascade reaction in producing new API’s (Active Pharmaceutical Ingredients).

Customer Challenge
Pharmaceutical company needed a reactive company to develop the enzyme expression, fermentation, and downstream processing parameters required for scaling up the production of a novel enzyme for their new API project. The enzyme manufacturing process needed to be developed and scaled up within a tight timeframe to support existing campaigns, whilst still ensuring the product met the narrow specifications required in terms of formulation, activity, and overall quality.

Approach
The initial enzyme discovery work undertaken by the pharmaceutical company formed the technical basis of the project our scientists built. We identified the best host for maximal expression and optimized our fermentation and downstream processing parameters to recover the highest possible titre of enzymes at the required quality. This included full assay development, allowing our team at Biocatalysts to work synergistically with the client, providing comparable data to their inhouse analysis technologies. This optimized process was developed with future scalability in mind.
Once the expression and recovery profile for the enzymes was proven, we worked with the client to define a full product specification and release criteria, ensuring the enzyme fit their API manufacturing process with respect to regulatory, supply chain, and logistical requirements. This ranged from product formulation requirements (purity, activity, carriers, etc) all the way through to packaging & handling. We are familiar with the technical requirements for API enzymes, as well as the global supply chain required to support API projects.
The development project leveraged multiple fermentation suites – from lab scale proof of concept in bench-top fermenters, to kgs of Quality Controlled material from industrial scale fermenters.

Outcome
The resultant enzymes were proven in-application with the client’s manufacturing partners and are now commercially available to them on demand.

Summary
Biocatalysts helps many pharmaceutical clients at various stages of enzyme discovery, product-development, scale-up, and supply, for applications in a wide range of processes. We have built a standalone business model specifically to support this approach, leveraging our short response times, our history in commercializing novel enzymes, and our lab-to-plant manufacturing scales. This minimises risk when commercialising enzymes for pharmaceutical applications. and ensures we can support existing R&D and campaign projects seamlessly.