An overview of single use manufacturing for the production of AAV gene therapy products with comparisons to traditional monoclonal antibody production.  Specific challenges of scaling up AAV production and considerations to accommodate a range of demands of differing gene therapy products will be discussed.  I will review the reasons for starting and the challenges of being the in-house manufacturing facility for a rapidly growing company.  The challenges of making non-COVID products in the era of Warp Speed along with future commercial production comparing fully single use with a hybrid facility will be explored.

Presented by Lance Marquardt, Associate Director -Upstream Processing Gene Therapy, Hopewell Biologics Manufacturing at PTC Therapeutics


Lance Marquardt is the Associate Director -Upstream Processing Gene Therapy for Hopewell Biologics Manufacturing at PTC Therapeutics bringing over 20 years of experience in the production of therapeutic proteins for clinical trials.  Lance was a key member of the team that revalidated and commissioned a fully single use facility to produce AAV gene therapy product.  The facility was previously designed and used manufacture of numerous antibody-based products.  He previously led the Upstream Processing group that transitioned from tradition reusable processing to a fully single use production processing at Bristol-Myers Squibb.  He received his BS degree in Biotechnology from the University of Wisconsin – River Falls and his MS degree from Kean University.

Downstream Processing Technology Solutions for AAV Vector Production

This presentation will cover an overview of Repligen’s downstream technologies that help in the development, scale-up and optimization of AAV purification processes. The technologies discussed will include TFF, Affinity Resins, Pre-Packed Columns and Analytics.

Presented by Vikas Gupta, Vice President and GM Downstream Bioprocessing and Gene Therapy at Repligen

Vikas Gupta is the Vice President of Downstream Bioprocessing and Gene Therapy at Repligen. He joined Repligen in March 2016 as Vice President of Business Development and Strategy.  He is currently responsible for managing the prepacked chromatography columns, affinity resins and flat sheet cassettes businesses and leads the gene therapy initiative in the company. Prior to joining Repligen, Mr. Gupta worked at GE Life Sciences from 2012 to 2015 in commercial leadership roles managing its Enterprise Solutions & Services business as well as the single-use and filtration portfolio.  Before GE, Mr. Gupta worked at Millipore from 2004 to 2011 in business development and product management roles, playing an instrumental role in the early growth of its Mobius® single-use bioprocessing business. He received his B.S. in Chemical engineering and an MBA from India, and an M.S. in Finance from Bentley University in Waltham, MA. 

Joining as Panelists in the Q&A session

Rachel Legmann, Senior Director of Technology, Gene Therapy at Repligen


Rachel has more than 20 years of experience in the field of scalable biologics and gene therapy manufacturing of therapeutic products, viral vectors and proteins for gene therapy and biologics. She completed her Ph.D. in Food Engineering and Biotechnology at the Technion-Israel Institute of Technology, Israel. Rachel joined Repligen in 2021 as a subject matter expert offering technical assistance to help customers achieve their technical and operational objectives in their manufacturing of virus-based therapeutics with a focus on gene therapy processes including upstream, downstream, analytics and scalability. In addition to supporting global customers and building high level networks, Rachel is supporting various internal cross-functional activities and external collaborations. Prior to joining Repligen, Rachel held several scientific and leadership roles at Microbiology & Molecular Genetics department at Harvard Medical School, CRO SBH Sciences, Seahorse Biosciences part of Agilent, CDMO Goodwin Biotechnology and Pall Corp part of Danaher.

Gilbert Huang, Senior Field Application Scientist at Repligen


Gilbert Huang has been with Repligen since 2021 and is currently a Senior Field Application Scientist. He earned a B.S in Biochemistry and Cell Biology from Rice University and a Ph.D. in Biochemistry and Molecular Biology from Baylor College of Medicine in Houston, Texas. He uses his expertise in biochemistry and separations technology to consult with customers on downstream process development.

Sponsored by Repligen

Inspiring advances in bioprocessing, Repligen is a technology leader in filtration, chromatography, systems, process analytics, and Protein A ligand development for bioprocessing and gene therapy. Propelled by a culture of innovation and collaboration, and with a focus on cost and process efficiencies, our people and our technologies help address critical steps in the production of therapeutics, vaccines, and diagnostics worldwide. Named one of the fastest growing biotech companies in the USA, Repligen is headquartered in Boston, MA with major manufacturing sites in Massachusetts, California, New Jersey, Sweden, and Germany.