Optimizing process development to simplify manufacturing scale up of therapeutic viral vectors

With the progress in developing new viral vector systems guided by safety, specificity and potency considerations, several gene and cell-based therapies are now close to being clinically approved and commercially available to treat genetic diseases. These viral vectors systems are based on the production of mainly adeno-associated viruses (AAV) and lentiviruses by transient transfection of human embryonic kidney (HEK)-293 derived producer cell lines.

One of the bottlenecks that needs to be addressed is optimization of production during Upstream Process Development to simplify manufacturing scale-up of therapeutic viral vectors to support advanced clinical trials and commercialization. This is why, virus vector production using the right transient transfection approach and combined cell culture system is crucial to achieve process performance, while complying with Quality requirements for process development and clinical-grade manufacturing. With the available quality grades of PEI, PEIpro^®, PEIpro^®-HQ and recently launched PEIpro^®-GMP, Polyplus-transfection^® offers a complete and reliable PEI transfection method that guarantees direct scalability and seamless transition from process development up to large-scale clinical-grade viral vector manufacturing.

During this On Demand you will hear from experts in transfection, advanced culture systems and gene therapy viral vector manufacturing to optimize your process development and simplify your manufacturing scale-up.

• Improve transfection step efficiency to optimise viral vector production
• Simplify and introduce flexibility to your vector scale-up process
• Ensure reproducability across various platforms
• Improve performance through reliable PEI sourcing
• Comply with raw material quality requirements for ATMPs throughout the transition to therapeutic/clinical-grade viral vector production
• Anticipate challenges with large-scale manufacturing

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Chris Lorenz

SVP, Technical Operations at

Chris Lorenz received his BS and MS in Chemical Engineering from Stanford University. He began his career at Genentech in their Early Stage Cell Culture department, developing new processes for Genentech’s pipeline of programs moving from Research into Development. He transitioned into a PD role focused on new technology evaluation with an emphasis on single-use technologies, and later joined their Manufacturing Science & Technology (MSAT) organization. In 2010, Chris joined Novartis Diagnostics on their Engineering team, and from there moved into Manufacturing where he managed various functions within Novartis’s immunodiagnostics operations (which was acquired by Grifols in 2014). Chris joined Audentes Therapeutics in early 2016, where he was brought in to start up their internal manufacturing operations from scratch. In late 2016, Audentes began GMP manufacturing for their pipeline of AAV-based gene therapy programs. He currently leads their AAV Process Development, Process Engineering, and Manufacturing functions.

Valerie Kedinger

GMP & Analytical Subcontractor Manager at Polyplus-transfection

Valerie Kedinger holds a PhD in Molecular and Cellular Biology from Strasbourg University. After a three-year postdoctoral fellowship in cancer research at McGill University (Montreal, Canada), she joined Polyplus-transfection® in 2011 as the in vivo R&D project leader to drive the development of in vivo nucleic acid delivery approaches in cancer treatment. Valérie went on to serve as in vivo and Bioproduction Application Specialist to provide scientific guidance to preclinical and clinical-stage Biotechs and Pharmas. Since 2018, Valerie is the GMP and Analytical Subcontractor Manager at Polyplus-transfection.

Rachel Legmann

Senior Cell Culture Process Development Manager at Pall Biotech

Rachel is partnering with sales, marketing and Pall’s technology teams to build company prominence as a preferred partner for the development and manufacturing of virus based therapeutics with a focus on Gene Therapy. In addition to supporting customers and building high level networks, Rachel is supporting various internal cross-functional activities including due diligence and new product development.

Rachel has more than 20 years of experience in the field of scalable biologics and gene therapy manufacturing of therapeutic products, viral vector and proteins for gene therapy and biologics. She completed her PhD in Food Engineering and Biotechnology at the Technion-Israel Institute of Technology, Israel. Rachel joined Pall in 2014 serving as a process development services senior lab manager in charge of upstream and downstream process development, scale-up, and manufacturing support activities for the gene therapy and biologics markets. Prior to joining Pall, Rachel held several scientific and leadership roles at Microbiology & Molecular Genetics department at Harvard Medical School, SBH Sciences (CRO), Seahorse Biosciences-Agilent, and Goodwin Biotechnology (CMO).

Kathy Webb

Senior Director, GMP, Upstream at Catalent Pharma Paragon Bioservices

Kathy Webb, MSChE, Senior Director GMP Upstream Manufacturing, is responsible for the upstream manufacturing operations at Paragon Bioservices and has experience with a variety of production processes utilizing stable cell lines, transient expression, baculoviral expression vectors, and microbial fermentation. Kathy has over 20 years of experience working in a contract development and manufacturing organization and has had evolving roles and responsibilities in process development, technical support and the manufacture of biologics. She has a M.S. in Chemical Engineering from the University of Illinois at Urbana-Champaign and a B.S. in Chemical Engineering from the University of Pittsburgh.

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SPEAKERS

Chris Lorenz

SVP, Technical Operations at

Valerie Kedinger

GMP & Analytical Subcontractor Manager at Polyplus-transfection

Rachel Legmann

Senior Cell Culture Process Development Manager at Pall Biotech

Kathy Webb

Senior Director, GMP, Upstream at Catalent Pharma Paragon Bioservices

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