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To develop GMP grade engineered protein capsules manufacturing process
October 12, 2016
By: Tim Wright
Editor-in-Chief, Contract Pharma
Contract development and manufacturing organization (CDMO) Cobra Biologics and Neuway Pharma, a biopharma company developing drugs for the treatment of severe orphan CNS diseases, will partner to develop a manufacturing process for the production of GMP grade material of engineered protein capsules (EPCs) using SF9 cells and subsequent baculovirus infection. The material will be used by Neuway for the conduct of GLP toxicity studies and initiation of clinical development in the treatment of Progressive Multifocal Leukoencephalopathy, a very severe neurodegenerative CNS disease. Neuway Pharma also uses its EPCs as a CNS drug delivery platform by filling them with active drug substances. “The initiation of GMP development is an important step towards qualification of EPCs for clinical development,” said Heiko Manninga, chief scientific officer and managing director, Neuway Pharma. “We are very happy that we have gained Cobra Biologics as partner for the GMP manufacturing of Engineered Protein Capsules.” Peter Coleman, chief executive officer, Cobra Biologics, said, “We are very pleased to be manufacturing Neuway Pharma’s EPCs for what is a rare but serious disease, often resulting in severe disability or death. With Cobra’s 17 years of virus production experience we hope this is just the beginning of our collaboration.”
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