Vigene Biosciences recently opened its $20 million, state-of-the-art lab and research facility, and global headquarters in Rockville, MD. Vigene has also entered a major strategic partnership with the California gene therapy company, ASC Therapeutics. 

Vigene provides viral vector-based gene delivery services and products; its mission to make gene therapy affordable. The company streamlines virus production from early conceptual stages to commercial manufacturing. The new 71-thousand square foot facility combines new manufacturing technologies and high yield production cell lines with the rigorous quality of cGMP and BSL-3.

Under the long-term partnership with ASC Therapeutics, Vigene will provide GMP manufacturing, including viral vectors and plasmid DNA, for its hemophilia A gene therapy clinical program, as well as a manufacturing platform for future gene therapy programs.

Vigene is listed on Inc. 5000 fastest-growing private companies in America for 2019 and 2018, named the 2018 ACG Emerging Company of the Year. The company started in Rockville, MD in 2012 with just five biotech experts. The company now employs 100, with plans to add as many as 80 more scientists, researchers and staff in the next year.

Contract Pharma talks with Dr. Jeffrey Hung, Chief Commercial Officer of Vigene Biosciences, about the strategic partnership, supporting manufacturing, and the future of cell and gene therapies. –KB

Contract Pharma: What are the main goals of the Vigene/ASC partnership?

Jeffrey Hung: The main goals of the Vigene/ASC partnership are twofold. First, we plan to support the current ASC clinical trial material manufacturing. The second goal is to provide the availability for GMP manufacturing capacity for the future clinical trial and commercial manufacturing for ASC. This partnership is an endorsement to Vigene’s GMP manufacturing capacity and capability for viral vectors in that ASC entrusts to Vigene for not only one project but also their pipeline of current and future gene therapy candidates.

CP: What are the current manufacturing challenges and how can they be overcome?

JH: This is a billion dollar question. The manufacturing challenges lie throughout the process.  Cell line productivity, upstream production, downstream purification, analytical services and QC testing. The solution is innovation, optimization and scaleup. Let me address them one by one from Vigene’s experiences.

Regarding innovation, we developed Vigene proprietary GMP level high productivity cell lines for viral vector production that has been demonstrated to be 2-3X more productive than current cell lines used by others. Regarding optimization, both the upstream process and downstream process can use more optimization to increase yield and reduce loss. From transfection we tested different transfection agents and different protocol, we have identified a protocol that generates 2-3X more productive than before. Regarding scaleup, Scaleup can save a lot on overhead, personnel and achieve lower cost per dose. To that end, Vigene built a state-of-the-art, up to 1000L, GMP production facility with full commercial production capability.

CP: What do you anticipate for the future of cell and gene therapies?

JH: We are only at the beginning of a new era. The future of cell and gene therapies is bright.  We are going to cure many diseases including both rare diseases and large indications through a new generation of cell and gene therapies. I see a few trends in the future of cell and gene therapies.

The first one is that more and more pharma and biotech companies will develop a pipeline of cell and gene therapies to address a large set of unmet medical needs from rare diseases to cancer to Parkinson diseases. The second trend is that the manufacturing capacity will continue to expand to meet the demand from biotech and pharma companies. The favorable safety profile of AAV will prove very useful to translate a gene therapy concept to a clinical candidate quickly to benefit patients. Lastly, is the continued innovation both on the manufacturing process and basic viral vector biology to make gene therapy more accessible and affordable to the public. Vigene is definitely focused on this mission.

---

Jeffrey Hung, Ph.D., is Chief Commercial Officer of Vigene Biosciences, a leading gene delivery company whose mission is to make gene therapy affordable. Dr. Hung orchestrated Vigene Biosciences’s acquisition of Omnia Biologics in 2016, a CMO specializing on GMP manufacturing of Viruses. Dr. Hung served as the Vice President of GenScript and was instrumental in growing the company before the IPO in December 2015. Dr. Hung was the Chief Marketing Officer at ATCC, the world’s largest biobank, before joining GenScript. Dr. Hung is the author of multiple patents, peer reviewed publications. Dr. Hung earned his Ph.D. from Cornell University, MBA from UC Berkeley, and BS from Peking University.