Search results Search for: Search Refine your results by duration: Any Under 5 mins Under 20 mins Over 20 mins Sort by: Relevance Views Date Material Requirements to Support Gene Therapy Development Clare Blue, Director of Analytical Development at Biogen and James Wilkinson, VP of Sales and Customer Success at Refeyn Manufacturing processes for gene therapy products are generally low yielding compared to production processes for other biologics. The material requir... 1 day ago | 73 mins Single Use Process for Production of AAV Gene Therapy Products Lance Marquardt, Associate Director -Upstream Processing Gene Therapy, Hopewell Biologics Manufacturing at PTC Therapeutics An overview of single use manufacturing for the production of AAV gene therapy products with comparisons to traditional monoclonal antibody production... May 26, 2022 2:00pm Cell&Gene therapy orchestration in a point-of-care production model Dell Technologies Join to learn more about a closed-loop supply chain in healthcare. Personalized treatments, like autologous cell therapies, are based on a concept th... 2 months ago | 32 mins CMC Progression from Early to Late Phase... Sarah Thomas, Vice President of Quality at REGENXBIO Inc. and Joanna Zmurko, NGS specialist at PathoQuest Full Title: CMC Progression from Early to Late Phase – Practical Considerations for Gene Therapy The principles for developing traditional biologics ... 2 months ago | 88 mins Cell&Gene therapy orchestration in a point-of-care production model Dell Technologies Join to learn more about a closed-loop supply chain in healthcare. Personalized treatments, like autologous cell therapies, are based on a concept th... 3 months ago | 32 mins 유전자 치료제 개발시 국제규제(Regulatory)환경에 맞춰 방향을 읽는 법 & 다양한 국제규제환경을 고려하여 성공적인 임상전략을 개발하는 법 Premier Consulting - Maurice Bancsi 이사, Regulatory Affair팀 웨비나를 통해서 제품 개발 및 승인과정을 간소화하기 위해 설계된 프로그램에 초점을 맞춰 유전자치료제 개발시 국제 규제(Regulatory)제도에 관하여 알아보세요. 또한 다양한 지역의 규제(Regulatory)제도와 임상 개발 프로그램에 대한 성공적인 규제(Regul... 2 months ago | 34 mins Enabling Scalable & Cost-Effective Point of Care for Cell & Gene Therapies Qasim Rafiq, Xavier de Mollerat du Jeu, Sean Chang The transformative potential to change the way human disease is treated using cell and gene therapy has motivated rapid technological advancements tow... 11 months ago | 62 mins Regulatory Strategies For Rapid Sterility Testing... Dr. Michael J. Miller, at Microbiology Consultants, LLC and Lori Daane, at bioMérieux Full Title: Regulatory Strategies For Rapid Sterility Testing of Gene and Cell Therapy Products The need to utilize rapid sterility testing is gainin... 2 months ago | 122 mins Analytical Challenges for Gene Therapy Clare Blue at Biogen and Saba Hussein at Vironova Presented by Clare Blue and Dr Saba Hussein One of the biggest challenges for AAV gene therapy products is establishing an appropriate analytical str... 2 years ago | 74 mins GMP Ancillary Materials for Cell & Gene Therapy Manufacturing: What to Consider Kasey Kime, Eric Roos This webinar covers regulatory requirements for GMP ancillary materials and the importance of regulatory documentation and support. Considerations for... 11 months ago | 43 mins Load more