Process Development: One Size Does Not Fit All

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SynCo Bio Partners believe that contract manufacturing should not be “one size fits all” and that the biopharmaceutical contract manufacturing industry needs to explore different collaborative business models in the development of production processes with prospective clients.

Most CMOs, including SynCo, offer complete, full process, and analytical method development from the upstream fermentation/cell culture stages to the final purification steps. For small virtual companies to larger organizations with limited available internal resources this can be a good option. However, for the client, loss of control over its development project can be a genuine concern.

There are a number of options for working with a CMO on a process development program including the following.

 

Outsource Full Process and Analytical Development

 

Outsourcing full process and analytical development to the CMO thereby empowers the CMO to deliver and simplifies reporting lines, which makes this type of project relatively easy to manage. However, this is can be an expensive option and the lack of control over the project and the process developed can be an issue. Solid relationships combined with excellent communication between the CMO and client should counter this.

 

Outsource Process Development Only

 

If outsourcing only process development to the CMO, a company develops analytical methods in-house (subsequently transferring to the CMO for qualification and batch release). This is a more complex project structure to manage, but because assays are developed in-house, the client retains a greater degree of control and internal staff remain engaged in the project.

 

 


 

 

Develop the Full Production Process In-House

 

A company can develop the full production process in-house, then contract a CMO to complete transfer and scale-up. This option does allow for full control and on the surface appears to be less expensive. However, process modifications would almost certainly be required to accommodate the chosen CMO. This transfer, process modification, and scale-up can be costly both financially and timewise compared to Option 1.

Alternatively, a company can develop the full production process in-house, but contract-in the CMO sooner to involve it on a consultancy basis in process development. This allows full control over the in-house, developed process but brings expertise in scale-up and process accommodation from the CMO to the project team earlier in development. This is likely to be the least expensive route, ensuring a streamlined technology transfer later to the CMO with minimal or no process modifications. However, few CMOs work according to this model, and good and open communication is essential to success.

SynCo Bio Partners, a Netherlands-based GMP CMO established in 2000, works with a broad client base on a range of biopharmaceutical development projects. These include the development of processes for the GMP manufacture of recombinant and wild type proteins, polysaccharides, and live-microbial-based products. SynCo has experience of all of the approaches outlined above and believes flexibility is paramount to client satisfaction. Whichever approach is taken, success is always dependent on establishing a strong and openly communicative partnership where both parties equally contribute to the successful delivery of the program.

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