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Under an NIH contract, Paragon Bioservices will design a manufacturing process for recombinant human rhE-selectin protein.
CDMO Paragon Bioservices has been awarded a contract from the National Institutes of Health National Institute of Neurological Disorders and Stroke (NINDS) to design and establish a scale-up manufacturing process for the cGMP production of the recombinant human rhE-selectin protein. The potential application of E-selectin in the clinic is based on the role that the compound plays in coordinating and responding to the immune system’s activation and resulting response.
Research on E-selectin at NINDS has been done by John Hallenbeck, MD, chief of the NINDS Stroke Branch and a senior investigator in the Institute’s Clinical Investigations section. Dr. Hallenbeck’s laboratory is studying the cellular regulation of ischemic tolerance and inflammatory and immune mechanisms in the initiation and progression of stroke. E-selectin control of molecular inflammation may help prevent thrombosis and hemorrhage and result in a new strategy for the prevention of recurrent strokes.
Paragon Bioservices has experience in process development and manufacturing of reagent-grade proteins and biopharmaceuticals utilizing the Baculovirus Expression Vector System (BEVS) and insect cells. Paragon was one of the first CDMOs to obtain a license from Texas A&M in 1991 to offer recombinant protein expression in insect cells, according to the company. Paragon intends to leverage its experience in insect cell culture and the BEVS to develop both transiently and stably transfected cell lines. A stable line offers the advantage of maintaining a single bank (of stably transfected insect cells) versus both master virus and master cell banks, noted the company in an interview with Pharmaceutical Technology. A parallel approach will use traditional baculovirus infection of insect cells for E-selectin protein expression and purification. Although establishing expression levels sufficient to meet client needs can be a challenge, it is accomplished by pursuing multiple parallel approaches and optimizing media and related culture and protein recovery conditions for the stable and baculovirus expression strategies, noted the company.
Paragon Bioservices anticipates that, beginning with nucleic acid sequence, it will take 15–20 months to create recombinants, optimize expression, and then scale processes to meet client requirements for quantity as well as cGMP-compliant production in anticipation of Investigational New Drug submission and early-phase clinical trials.
Source: Paragon Bioservices