A ddPCR primer: advantages, challenges, and key considerations when adopting Droplet Digital PCR for viral vector manufacture

Abstract

<div class="authors authors-lg"><div class="author"><div class="author-img"><img src="https://cdn.insights.bio/uploads/Drouin_headshot.jpg" data-image="1"></div><div class="author-det"><h3 class="author-name" style="color: rgb(93, 83, 138);">Lauren M Drouin</h3><h5 class="author-title" style="color: rgb(93, 83, 138);">Associate Director of Analytical Development, LogicBio TherapeuticsAssociate Director of Analytical Development, LogicBio Therapeutics</h5> Lauren M Drouin leads the Analytical Development group at LogicBio Therapeutics, where she supports the development and implementation of analytical methodologies needed to progress LB-001 and other pipeline products from preclinical development into the clinic and beyond. Current research interests include novel AAV capsid characterization and developing a robust understanding of the factors that influence potency of gene therapy products. Previously, Lauren worked at Voyager Therapeutics where she was responsible for analytical method development and overseeing CMC analytics operations for the Parkinson’s Disease clinical program. Lauren received her PhD in Biochemistry and Molecular Biology from the University of Florida where she utilized molecular, biophysical, and structural techniques to characterize the AAV capsid for improved gene delivery. </div></div></div><div class="authors authors-lg"><div class="author"><div class="author-img"><img src="https://cdn.insights.bio/uploads/F Dorange photo copy.jpg" data-image="1"></div><div class="author-det"><h3 class="author-name" style="color: rgb(0, 167, 149);">Fabien Dorange</h3><h5 class="author-title" style="color: rgb(0, 167, 149);">Head of Analytical CMC, Genethon</h5> Fabien Dorange holds a PhD in virology and worked as a postdoctoral researcher in the gene therapy field. Before joining Genethon, Fabien was Head of R&amp;D viral safety in a CRO company (Texcell, France). He joined Genethon in 2016 and currently heads of the CMC Analytical Department. He is responsible for the analytical activities in the characterization and release testing of gene therapy products. </div></div></div><div class="authors authors-lg"><div class="author"><div class="author-img"><img src="https://cdn.insights.bio/uploads/Bsilvey_headshot_2021 copy.jpg" data-image="1"></div><div class="author-det"><h3 class="author-name" style="color: rgb(0, 117, 137);">Bryan Silvey</h3><h5 class="author-title" style="color: rgb(0, 117, 137);">Head of Quality, A2 Biotherapeutics</h5> Bryan Silvey has been in the biopharmaceutical industry for over 25 years in both Quality technical roles and Regulatory Affairs CMC leadership positions having responsibilities for both product and facilities lifecycle management. Global experience in regulatory authority requirements and expectations in the CMC space with biologics has proved a grounding platform of quality principles that he has applied to successful development and commercialization of two (2) CAR T-Cell therapies while at Kite (a Gilead Company). As Head of Quality for A2 Biotherapeutics, an early stage cell therapy discovery and development company, this journey in CMC science continues to push forward in an effort to address unmet cancer patient needs. </div></div></div><div class="authors authors-lg"><div class="author"><div class="author-img"><img src="https://cdn.insights.bio/uploads/Mark Head Shot 2020 copy.jpg" data-image="1"></div><div class="author-det"><h3 class="author-name" style="color: rgb(85, 85, 89);">Mark White</h3><h5 class="author-title" style="color: rgb(85, 85, 89);">Associate Director of Biopharma Product Marketing, Bio-Rad</h5> Mark White is the Associate Director of Biopharma Product Marketing at Bio-Rad. He has played a key role in the development of multiple core technology capabilities and assays alongside a multidisciplinary team of biologists and engineers at Bio-Rad and previously at Berkeley Lights Inc. Mark obtained his PhD in Biomedical Sciences at the University of California, San Francisco. </div></div></div><div class="authors authors-lg"><div class="author"><div class="author-img"><img src="https://cdn.insights.bio/uploads/Pincus copy.jpg" data-image="1"></div><div class="author-det"><h3 class="author-name" style="color: rgb(0, 59, 76);">Steven Pincus</h3><h5 class="author-title" style="color: rgb(0, 59, 76);">Executive Director Analytical Development, Neurogene</h5> Steven Pincus has a PhD in Biochemistry with training in molecular Virology and Immunology. Steven has over 30 years in the biotech industry leading teams in research and development of vaccines, AAV Gene Therapies and monoclonal antibodies in the areas of infectious disease, autoimmune disease and cancer. He has taken projects from discovery through Phase 2 clinical trials. He has developed qualified and validated release assays and assays for measuring clinical and immunological responses. He has led the transfer of assays to partners, developed and managed collaborations with academic and industrial partners, managed CRO’s and developed and managed project budgets and goals. During his career Steven has gained experience in Quality control, analytical development, regulatory affairs and manufacturing development for vaccines and Gene Therapies. He is currently Executive Director Analytical Development at Neurogene. </div></div></div>