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 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 – 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.

Contact us to support and de-risk your manufacturing campaign

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.

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