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Cook Pharmica, LLC and Selexis SA Establish Customized Biologic Drug Development and Manufacturing Services Platform

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Preliminary Data from the Successful Proof-of-Concept Program
Published in the June Issue of BioProcess International

(Bloomington, Indiana and Geneva, Switzerland – June 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.

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. [1]

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.[2]

[1],2,3 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

About Cook Pharmica LLC

Cook Pharmica is an integrated contract development and manufacturing organization providing the pharmaceutical and biopharmaceutical industries with drug substance manufacturing from mammalian cell culture, analytical and formulation development, parenteral manufacturing in vials and prefilled syringes, lyophilization, and secondary packaging. Operating with more than 400 employees in a 900,000 square foot, $200 million facility in Bloomington, Ind., Cook Pharmica’s mission is to consolidate and simplify clients’ contract manufacturing into one source at one location. Founded in 2004, Cook Pharmica, the biopharmaceutical manufacturing division of Cook Medical, is a privately held, wholly owned subsidiary of the parent company Cook Group. For more information, visit www.cookpharmica.com.

Media Contact

Caitlin Wenz
Specialist, Public Relations, Cook Medical
Office: 812.339.2235 ex. 4245
Mobile: 812.327.4433
caitlin.wenz@cookpharmica.com