Following completion of fermentation process development (both the upstream and downstream process), transfer of a developed USP and DSP process to a scaled manufacturer and successful manufacture campaigns are often critical, but high-risk activities in a project if not carried out via a suitable process.
The team at Isomerase are skilled at all aspects of tech transfer after fermentation process development - generating robust processes and detailed documentation for scaleup and transfer to CDMOs, generating and sending out requests for quote (RFQ) to potential CDMOs, then helping selection of the most appropriate supplier, technical transfer of the process and then management of the process life cycle, for example by putting “boots on the ground” to ensure successful tech transfer.
What criteria are important for the selection of a scaled CDMO?
No specific CDMO is perfect for every process. Isomerase has a large network of CDMOs that we can work with the place your process. There are multiple factors that can be important to a potential client:
Regulation – CDMOs often specialise in either GMP or non-GMP processes, or may operate under different regulatory environments, e.g. Products for human consumption.
Experience with processes or strains – Following fermentation process development it can sometimes be valuable to place a process with a CDMO that has some experience with a particular type of process or microbial strain. For example filamentous bacteria, such as actinomycetes or a methanol-based Pichia process. This experience can make success more likely, as the CDMO is more likely to notice potential issues and have the correct equipment for the process, without needing to access or loan equipment they may be less familiar with.
Specific USP or DSP equipment – There is a wide range of USP and DSP equipment and no one manufacturer has all options available to them. For example, the capability to handle solvents or pure oxygen in a process, different types of separation equipment can lead to differences in wetness and form of separated cells or drying equipment for a certain scale, such as lyophilisers or spray dryers.
HPAPIs – Many facilities will not handle high-potency APIs (HPAPIs).
GMOs – Some CDMOS prefer not to work with GMOs.
Sporulating microbial strains – Some CDMOs avoid sporulating organisms due to concerns with downstream removal from equipment.
Biosafety (BSL) category – CDMOs will be rated to handle a specific BSL category. A BSL-2 Mycobacterium, for example, will require BSL-2-rated facilities.
Equipment specifications – different providers have different reactor geometric configurations like vessel size, aspect ratio, impellor/turbine designs, pumping and control capabilities, filtration and separation chemistries and capabilities that could influence process adoption after fermentation process development.
Why is tech transfer important after fermentation process development?
Successful fermentation process development generates a scalable upstream and downstream process, however robustly transferring these processes to a manufacturer (CDMO) at the required scale, quality and location is a critical activity, which needs to be carried out effectively.
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 reduced costs and quicker time to market.
Commercialization: Tech transfer acts as the bridge between a successful lab-scale process after fermentation process development and actual scaled product production. Without an effective tech transfer, promising fermentation processes and biotechnology products could remain confined to the research bench, 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) and product consistency at greater volumes.
Regulatory compliance: Depending on the product, strict regulations and quality control standards may apply. Tech transfer ensures all process knowledge and data are transferred 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. Through proper tech transfer, this valuable knowledge is preserved and transferred to external manufacturing teams, facilitating future process optimization and innovation.
Contact us to support your manufacturing campaign with fermentation process development and tech transfer
Get in touch today to discuss your manufacturing campaign and how we can support the scaleup of your process or tech transfer to a CDMO.