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Vector Manufacturing PROGRAM

The NIIMBL Viral Vector program will develop and adopt technologies related to vector manufacturing.
Categories
Cell and Gene therapies

Solution

There is a clear need and opportunity for NIIMBL to play a role in the development and adoption of technologies related to vector manufacturing. The two most important vector platforms in use in the industry today involve the production of lentiviral vectors (LV) and adeno-associated virus (AAV) vectors. NIIMBL is well-positioned to bring together the appropriate resources to accelerate development of core manufacturing process platforms and essential analytical capabilities for viral vector product and process characterization. Advances in both areas are critical for broad and rapid expansion of the emerging industry of gene-based therapeutics and ultimately the many patients and families who stand to benefit from access to these novel therapies. 

Establishment of industrially-relevant NIIMBL platform processes for AAV and LV production could significantly enhance access to and utility of viral vectors for gene-based therapeutic research and development. Such processes could be made 'open' to the NIIMBL and broader community and made available as a standard process for academic and small companies.  These processes can be used to develop a shared understanding in discussions with health authorities, support activities of the bespoke gene therapy manufacturing initiative and potentially other consortia, and be used as a platform for innovating new technologies. 

Click here for a more detailed overview of the Viral Vector Program.

Updates, Related Publications, and Deliverables

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Project Lead

NIIMBL

NIIMBL

Participating Organizations

Alliance for Regenerative Medicine

Alliance for Regenerative Medicine

AstraZeneca

AstraZeneca

Batavia Biosciences Inc

Batavia Biosciences Inc

Bristol-Myers Squibb

Bristol-Myers Squibb

Cytiva

Cytiva

Eli Lilly and Company

Eli Lilly and Company

Federal Stakeholder:  National Institute of Standards and Technology

Federal Stakeholder: National Institute of Standards and Technology

Federal Stakeholder: Food and Drug Administration

Federal Stakeholder: Food and Drug Administration

Genentech

Genentech

Joan & Sanford I. Weill Medical College of Cornell University

Joan & Sanford I. Weill Medical College of Cornell University

Landmark Bio

Landmark Bio

Lonza Biologics, Inc.

Lonza Biologics, Inc.

MilliporeSigma/EMD Serono

MilliporeSigma/EMD Serono

North Carolina State University

North Carolina State University

Pfizer, Inc.

Pfizer, Inc.

Sartorius Stedim

Sartorius Stedim

Spark Therapeutics, Inc.

Spark Therapeutics, Inc.

United States Pharmacopeial Convention

United States Pharmacopeial Convention

University of Florida

University of Florida

University of Massachusetts Medical School

University of Massachusetts Medical School

University of Massachusetts System

University of Massachusetts System

Virica Biotech Inc.

Virica Biotech Inc.