Preliminary Data from the Successful Proof-of-Concept Program Published in the June Issue of BioProcess International
(Bloomington, Indiana and Geneva, Switzerland – June 24, 2014) – 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.
This program combines 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 brings overall shortened timelines and economic benefit to customers, resulting in accelerated delivery of drugs to the clinic and potentially the market.
In a nine-month proof-of-concept program, Cook Pharmacy and Selexis were able to successfully 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 rapidly scalable development process at their state-of-the-art cGMP biologics manufacturing facility in Bloomington, IN. 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. Preliminary data from the proof-of-concept program has been published in the June issue of BioProcess International in an article title “Rapid Development and Scale-Up Through Strategic Partnership: Case Study of an Integrated Approach to Cell-Line and Process Development for Therapeutic Antibodies.”1
“These preliminary data from the proof-of-concept confirmed our ability 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 yields commercial-ready titers with minimal development,” according to Cook Pharmica’s Vice President and Chief Scientific Officer, Vic Vinci, PhD. “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. We have now demonstrated that you can quickly go from DNA to protein in an optimized and seamless process,” said Igor Fisch, PhD, 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.”
Learn more by visiting www.cookpharmica.com or www.selexis.com to view and download the case study detailing this successful collaborative model for expediting early phase development.
About Cook Pharmica
Cook Pharmica is a privately held contract development and manufacturing organization (CDMO) that provides biopharmaceutical companies with a unique one-source, one-location model for development, clinical and commercial cell culture manufacturing, formulation, parenteral product manufacturing and secondary packaging. Centrally located in Bloomington, Indiana, Cook Pharmica is a wholly owned subsidiary of the Cook Group, which includes the largest privately held medical device manufacturer in the world, Cook Medical. The company maintains a simple goal: to deliver quality product in a timely manner. To do this effectively, Cook Pharmica has invested heavily in its facility, people and processes.
1. K Dhanasekharan, et al. Rapid Development and Scale-Up Through Strategic Partnership: Case Study of an Integrated Approach to Cell Line and Process Development. BioProcess Intl. 12(6)s 2014: 38–41.