Developing a biosimilar in nine months

25.06.2014 09:44

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Cook Pharmica, LLC, a leading biopharmaceutical contract development and manufacturing organization (CDMO), and Selexis SA, a serial innovation company focused on biologic drug discovery and mammalian cell line development, have built a platform program to offer biopharmaceutical clients an integrated development and manufacturing solution for biologic drugs. In a nine-month proof-of-concept program, Cook Pharmica and Selexis were able to develop, transfer and scale up a commercially available monoclonal antibody.

Preliminary data from the Cook/Selexis-sponsored proof-of-concept program has been published in the June issue of BioProcess International in an article titled, “Rapid Development and Scale-Up Through Strategic Partnership: Case Study of an Integrated Approach to Cell-Line and Process Development for Therapeutic Antibodies.”

This program combined key strengths of both companies. From the generation of stable and high performance CHO cell lines at Selexis to rapid process development, scale-up, cell culture manufacturing and final packaged sterile drug product manufacturing at Cook Pharmica, the collaboration optimized development timelines, according to the case study.

In a nine-month proof-of-concept program, Cook Pharmica and Selexis were able to develop, transfer and scale up a commercially available monoclonal antibody. Selexis generated a high performance SURE CHO-M cell line expressing a monoclonal antibody (biosimilar) that was transferred and used with Cook Pharmica’s scalable development process at their cGMP biologics manufacturing facility in Bloomington, IN. In this pilot program, the process developed between Selexis and Cook achieved titers above 3.5 g/L in 20L bioreactors and the purified monoclonal antibody product demonstrated full similarity in size, charges and glycan structure as compared to the innovator drug.

The program demonstrated the viability of using a commercially available model molecule to scale up from 2-L through a 20-L pilot scale process that is scalable to GMP operations for clinical production.

“These preliminary data from the proof-of-concept confirmed our ability in this case study to create a reliable process for the transfer and scale-up of a high expressing, stable clonal cell line, via a technology platform approach, that yielded commercial-ready titers with minimal development under the conditions of the study,” according to Cook Pharmica’s vice president and chief scientific officer, Vic Vinci, Ph.D. “In addition to this proof-of-concept program, we are very experienced in working with Selexis cell lines and are excited to be collaborating more with the Selexis team in the near future.”

“We are extremely pleased with the data and the platform realized timeline from the Selexis/Cook Pharmica proof-of-concept program. In this program, we demonstrated that you can quickly go from DNA to protein in an optimized and seamless process,” said Igor Fisch, Ph.D., CEO, Selexis SA. “This is another excellent example that Selexis can transfer a stable and high expressing clonal cell line to a CDMO with predicable results.”

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Fascinating technology