NEUWAY Pharma and Cobra Biologics collaborate to develop GMP-grade engineered protein capsules (EPCs) manufacturing process
Collaboration supports GLP toxicity studies and initiation of clinical development for the treatment of progressive multifocal leukoencephalopathy
Cobra Biologics, an international CDMO of biologics and pharmaceuticals, and NEUWAY Pharma GmbH, a biopharmaceutical company developing drugs for the treatment of severe orphan CNS diseases, have announced the conclusion of a service agreement 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 to conduct GLP toxicity studies and initiate clinical development for 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.
Dr Heiko Manninga, Chief Scientific Officer (CSO) and Managing Director of NEUWAY Pharma, commented: 'The initiation of GMP development is an important step towards the qualification of EPCs for clinical development. We are very happy that we have gained Cobra Biologics as partner for the GMP manufacturing of EPCs.'
Peter Coleman, CEO Cobra Biologics, commented: '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.'
