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 AGC Biologics was to develop a robust, scalable manufacturing process for this molecule, including defining the glycosylation parameters, implementing our glycan assay, and meeting the client’s production level requirements.
The Challenge
Develop and validate manufacturing processes for two novel molecules, one in phase 1 development and the other in phase 3.
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, AGC Biologics can deliver at least 500 grams of monoclonal antibody manufactured under cGMP in just 12 months for €2 million.
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.
The Challenge
Evolving from the well-established GMP 48L Nunc™ Cell Factory™ (CF) process, identify an effective, replicable, and large-scale lentiviral vector (LVV) manufacturing process to meet the growing manufacturing demand – especially for market application – without affecting critical quality attributes.