Tech Transfer and Scale Up

Once a fermentation process development campaign establishes and validates a robust upstream and downstream process, our clients can initiate scale-up to manufacturing.

Manufacturing overview

Manufacturing campaigns are critical for the commercialization of a client's target compound. Economies of scale allow for large quantities of product at a lower per-unit cost. However, the increased initial investment can make such scale increases high-risk.

When working with our fermentation process development team, our clients can feel confident that parameters at the lab and pilot scale have been chosen with commercialization in mind. Our expert team generates robust processes with clear, detailed documentation, ensuring consistency across scales.

With a deep understanding of fermentation parameters and the machinery required, our team can assist you in finding the ideal Contract Development and Manufacturing Organization (CDMO) for projects that require greater than 30 L scale.

We make CDMO selection easier

Our teams can bring you in touch with CDMOs that best fit your process, location, and budget.

CDMO selection and management - How can we help?

1. Send out requests for quote (RFQ) to potential CDMOs.

2. Help create a contractor shortlist of those that best fit your fermentation process requirements.

3. Initiate technical transfer of the process.

4. Followed by management of the process life cycle, which can involve site visits.

Which criteria are important when selecting a scaled CDMO?

No specific CDMO is perfect for every fermentation process. Isomerase has a large network of CDMOs that we can connect you with.

Client fermentation development requirements may include:

• Regulation: CDMOs often specialize in either GMP or non-GMP processes. Furthermore, certain contractors may operate under different regulatory environments, e.g., products for human consumption.
• Experience with fermentation processes or strains: It can be valuable to place a process with a CDMO that has experience with a similar process type or microbial strain.
• Specific USP or DSP equipment: Picking a facility that has the appropriate range of upstream equipment (media preparation and fermentation vessels) and downstream equipment. Downstream equipment can be product-specific but can include cell separation, lysis and clarification, filtration, and drying.
• Use of flammable: Oxygen enrichment is a method used to increase cell number at scale. As aeration becomes less effective at scale, introducing a higher oxygen concentration can help increase biomass. Furthermore, fermenting Pichia pastoris often uses methanol as a metabolite. Many CDMOs cannot handle flammables on-site.
• HPAPIs: Many facilities do not handle high-potency APIs (HPAPIs).
• GMOs: Some CDMOS cannot work with GMOs, particularly in the food and ingredient space. 
• Sporulating microbial strains: Some CDMOs avoid sporulating organisms due to concerns with downstream decontamination of their equipment.
• Biosafety (BSL) category: CDMOs are rated to handle a specific BSL category. A BSL-2 Mycobacterium, for example, will require BSL-2-rated facilities.
• Bioreactor geometry: Different providers have different bioreactor geometric configurations. Vessels vary in overall liquid capacity, aspect ratio, impeller/turbine designs, and pumping and control capabilities. These must remain consistent when scaling fermentation process development.

Why is tech transfer important after fermentation process development?

While successful fermentation process development results in scalable upstream and downstream operations, the robust transfer of these processes to a manufacturer (CDMO) that could meet the required scale, quality, and facility location is critical.

Important aspects of tech transfer after fermentation process development are as follows:

• Reduced risks and costs: Effective tech transfer minimizes the chance of roadblocks and delays during scale-up. This translates to lower costs and a reduced time to market.
• Commercialization: Tech transfer acts as the bridge between a lab-scale process, after a successful fermentation process development, and industrial-scale production. Without an effective tech transfer, promising fermentation processes and biotechnology products could remain confined to the research lab, failing to reach consumers.
• Scalability: Fermentation processes often need scaling up for commercial production. Tech transfer involves translating the small-scale lab or pilot-scale process to larger equipment and manufacturing environments, ensuring efficiency and typically much improved technoeconomics (e.g. reduced overall cost of goods).
• Regulatory compliance: Depending on the product, strict regulations and quality control standards may apply. Tech transfer ensures that all process knowledge and data are handed over to manufacturing partners, enabling quality, compliance, and safe production.
• Knowledge capture and dissemination: Document generation during fermentation process development and tech transfer ensures that process documents, expertise, and troubleshooting strategies developed during the R&D phase are not lost. Proper tech transfer preserves this valuable knowledge for external manufacturing teams.

How can Isomerase help prepare my fermentation process for manufacture?

We help partners from the lab/pilot scale all the way through to manufacturing. Our team of fermentation specialists' vast industry knowledge can also help you through the tech transfer process when scaling beyond 30 L.