Cytiva and BioCentriq, a New Jersey based cell and gene therapy contract development and manufacturing organization (CDMO,) have been awarded funding from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), 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 a minor part of NIIMBL’s $15.8M 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 (AAV) manufacturing process. The aim is to develop new standards that can be used for AAV and advance the development and adoption of gene therapies.
Emmanuel Abate, President, Genomic Medicine, Cytiva, says: “As pointed out in our 2023 Global Biopharma Resilience Index, collaborations are essential to solve the challenges of bringing future therapeutics to market. 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.”
The Global Biopharma Resilience Index, a survey of 1250 industry executives and partners, finds that the category of R&D collaborations needs urgent attention. 44% of respondents to the research believe that both traditional pharma and biopharma firms have a widespread culture of cooperation and open innovation, but just 34% believe the same about private companies, 32% about academic institutions, and fewer than 30% about government think tanks and CDMOs. The collaboration between Cytiva and BioCentriq is bucking this trend, demonstrating the value that can be created by bringing different perspectives together.
Haro Hartounian, PhD, CEO of BioCentriq, says: “We are thrilled to be selected to work on this project at such a crucial time for the industry. 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. We feel lucky to collaborate with such a committed organization like Cytiva in these efforts."
This work is performed under financial assistance award #70NANB21H086 from the U.S. Department of Commerce, National Institute of Standards and Technology.