Resources

Case Studies

Robust, Scalable Manufacturing: N-Linked Glycan Analysis for Complex Glycoproteins

The Challenge
The client had an established cell line and a bench-scale manufacturing process for a complex glycoprotein that produced high quality material but had a low yield and was not scalable. With plans to move into clinical development, the challenge for CMC Biologics was to develop a robust, scalable manufacturing process for this molecule, including defining the glycosylation parameters, implementing CMC Biologics’ glycan assay, and meeting the client’s production level requirements.

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Quality by Design: The Highest-Standard Approach to Process Validation for Early and Late-Stage Projects

The Challenge
Develop and validate manufacturing processes for two novel molecules, one in phase 1 development and the other in phase 3.

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Get your antibody produced right. On time.

The Challenge
Accelerating the development and manufacture of monoclonal antibodies is critical for reducing the time it takes to move a promising therapy from bench to clinic. Most early-stage biopharmaceutical companies lack the internal resources to develop and optimize a production cell line and manufacturing process and to conduct cGMP manufacturing. Larger companies that have those resources may lack the capacity to produce multiple antibodies simultaneously. Wherever your company is in its evolution, CMC Biologics can deliver at least 500 grams of monoclonal antibody manufactured under cGMP in just 12 months for €2 million.

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Optimizing a Perfusion Manufacturing Process for Commercial Production

The Challenge
Optimize and scale-up a bench-scale perfusion manufacturing process for a client developing its first recombinant DNA-based product. Perfusion manufacturing presents a unique set of challenges because the addition of media and harvesting of material is done on an ongoing basis, which makes it more difficult to maintain consistent conditions over the course of the manufacturing campaign. Additionally, because material is harvested only from the media, cells need to be separated from the media at the time of harvest and then returned to the bioreactor without undergoing damage or stress that could alter protein production. The project required scale-up of a complex process and development of validated analytics that would support commercial manufacture.

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