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In December 2019, Cytiva and the University of Massachusetts Medical School (UMMS) announced their intent to establish a large-scale viral vector manufacturing facility to provide high-quality recombinant adeno-associated virus (AAV) vectors for preclinical research. This partnership aims to accelerate novel gene therapies to patients.

Reducing development timelines and alleviating bottlenecks

Preclinical research capabilities are limited due to a lack of large-scale viral vector manufacturing facilities. Researchers often must wait 12 to 24 months to secure enough vector for their research. Also, most other suppliers have good manufacturing practices (GMP) infrastructure costs. Non-human primate studies do not require GMP-grade vector, so good laboratory practices (GLP)-grade AAV manufactured at the facility is cost effective. The GLP-grade vector from the new facility can be developed within a much shorter lead time from receipt of a purchase order (PO).

Furthermore, researchers have access to the combined benefits of Cytiva’s industry-leading development platforms and processing equipment and UMMS assistance of professional and scientifically knowledgeable staff at the facility to help get their research to the clinic faster.

The large-scale manufacturing facility at the UMMS, located in the Horae Gene Therapy Center, is 3220 square feet in size and features GLP viral vector FlexFactory™ manufacturing platforms, which integrate many of Cytiva’s systems for AAV production. Six professional staff manage the day-to-day operation of the facility, which is now fully operational.

The UMMS facility offers solutions for AAV production using . The production scale ranges from investigational gene therapy studies that require small-scale GLP AAV production to translational gene therapy research that requires large-scale GLP AAV production. These scales can be further developed into the GMP AAV production scale that is required for clinical and commercial gene therapy through the Mass Biologics-UMMS partnership.

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Why UMMS and Cytiva?

UMMS provides a world-renowned ecosystem for gene therapy, led by internationally recognized scientists who have pioneered research in gene therapy and have deep scientific knowledge.

“We are very excited by this partnership with Cytiva and the addition of this large-scale AAV service to the Horae Gene Therapy Center. It now allows my team to support our collaborators in all of their preclinical AAV supply needs to help them bring their therapies to patients faster.” says Guangping Gao, PhD the Director of the UMMS Horae Gene Therapy Center and Viral Vector Core. He is also the president of the American Society for Gene & Cell Therapy (ASGCT). Dr. Gao played a key role in the discovery and characterization of a new family of AAV serotypes, which was instrumental in reviving the gene therapy field, hugely impacting many currently untreatable human diseases. Robert Kotin, PhD is one of the world’s top experts on the viral transport of gene therapies. A former NIH scientist and executive at Voyager, Dr. Kotin has played a sizable role in shaping the field.

Cytiva has a rich and long legacy of providing world class, cutting edge manufacturing platforms that can be tailored to project-specific viral vector production requirements. In addition, Cytiva has expertise in taking companies from small scale to large scale.

 

Customer testimonial

“We have used the UMass Vector Core to produce small-scale recombinant adeno-associated vector preparations for 12 years. These AAV vector preparations have supported early proof of concept studies for multiple programs. The Vector Core team has provided exceptional service and high quality AAV vector in a timely manner.” said Denise Woodcock, senior scientist, vector production and gene therapy, Sanofi.

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