Cytiva and BioCentriq, a New Jersey-based cell and gene therapy contract development and manufacturing organization, or CDMO, have been awarded funding from the National Institute for Innovation in Manufacturing Biopharmaceuticals, a public-private partnership whose mission is to accelerate biopharmaceutical innovation.
Viral clearance is a key regulatory requirement for all biopharmaceutical processes, but is a relatively new topic in cell and gene therapy.
This project, which is being granted funding as part of NIIMBL’s $15.8 million initiative to drive biotechnology innovation through technology and workforce development, will involve the creation of a viral and exotoxin clearance platform in an adeno-associated virus manufacturing process. The aim is to develop new standards that can be used for AAV and advance the development and adoption of gene therapies.
“As pointed out in our 2023 Global Biopharma Resilience Index, collaborations are essential to solve the challenges of bringing future therapeutics to market,” Emmanuel Abate, president, genomic medicine, Cytiva, said.
“Cytiva and BioCentriq can bring the combined intellectual power of both organizations to develop the solutions needed to advance the AAV manufacturing process and the genomic medicine industry.”
Dr. Haro Hartounian, CEO of BioCentriq, agreed.
“Achieving robust and scalable viral clearance for one of the most commonly used viral vectors is a major step toward achieving true scalability and reducing cost of goods.”