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Scale up and Risk Mitigation of Therapeutic Viral Vectors for Gene Therapy
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- 60 Minutes
With multiple products on the market, gene therapy has now gone beyond proof of concept and entered mainstream healthcare. This success urgently requires work on manufacturing processes to ensure that gene therapies are widely available to all that need them. Furthermore, regulatory authorities, tasked with assuring quality, efficacy and safety of the final product, are placing increasing scrutiny on the manufacturing process. Regulatory guidance documents suggest that the risk of adventitious agent contamination should be assessed and mitigated through a risk-based approach.
Participants will learn:
- What factors to consider when choosing your cell culture
- The advantages and disadvantages with each type of culture
- A risk based approach for viral vector manufacturing
Dr. Clive Glover
Director, Cell & Gene Therapy
Dr. Clive Glover is the Director of Cell & Gene Therapy at Pall Biotech. Clive leads Pall’s cell and gene therapy business. He has over 15 years of experience in cell and gene therapy. His work has been published in numerous scientific journals, and he has presented at many conferences. Previously he was responsible for driving product development efforts around cell therapy at GE Healthcare and has also held positions in marketing and product management at STEMCELL Technologies. Clive holds a PhD in Genetics from the University of British Columbia. When not at work, Clive spends a lot of time singing in Welsh choruses and hiking the Welsh hills.
Dr. Rachel Legmann
Director, Technical Consultancy, Gene Therapy & Viral Vectors
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 global 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 Ph.D. in Food Engineering and Biotechnology at the Technion-Israel Institute of Technology, Israel. Rachel joined Pall in 2014 and currently serves 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, Seahorse Biosciences, and Goodwin Biotechnology.
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