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 From Product Characterization to Clinical Reliable Specifications André Mischo, Associate Director Science & Technology at Novartis Defining product ranges needs to consider to assure product quality / efficacy and patient safety. One further element is that wide product ranges are... 2 months ago | 30 mins Single Use Process for Production of AAV Gene Therapy Products Lance Marquardt at PTC Therapeutics, Vikas Gupta, at Repligen, Rachel Legmann at Repligen, and Gilbert Huang at Repligen An overview of single use manufacturing for the production of AAV gene therapy products with comparisons to traditional monoclonal antibody production... 1 month ago | 120 mins Designing and Conducting Decentralized Dermatology Trials Premier Research Implementing rigorous assessments and securing the highest quality of data are major goals in dermatology clinical research. Traditional clinical tria... June 30, 2022 1:00pm An impurity detected in a stability study... Petra Booij, Investigator bij GlaxoSmithKline and Ward D’Autry, PhD Study Director at Nelson Labs Europe Full Title: An impurity detected in a stability study: Did we miss anything in our E&L risk assessment? Extractable and leachable (E&L) testing are r... 3 months ago | 90 mins Successful Scale Up of a High Yielding Viral Vector Suspension Platform to 500 L John Ketz, at Andelyn Biosciences, Denis Kole, at Pall Corporation and Benben Song, at Pall Corporation As gene therapies move toward commercialization, the journey to manufacture a high-quality product while achieving economies of scale and reducing fac... July 12, 2022 2:00pm Challenges In Therapeutic Biological Products Paolo Grisostomi at Biogen, Donald Young Thermo Fisher Scientific and Dr. Sona Kovackova at Nelson Labs Europe Presented by Paolo Grisostomi, Senior Engineer, Materials Science at Biogen and Donald Young, Sr. Product Manager at Thermo Fisher Scientific August 18, 2022 2:00pm Development of Drug-Device Combination Products with codebeamer X Bernhard Müllinger, General Manager, Resyca and Danish Mairaj, Principal Engineer, Resyca Rescya is an innovative provider of advanced drug delivery technologies, focusing on user-friendly soft mist inhaler devices. As a company operating a... 4 months ago | 54 mins Rapid methods- The Next Phase : A Framework For Multi-Product Adoption... Miriam Guest, at AstraZeneca UK and Ulrich Herber at Charles River Full Title: Rapid methods- The Next Phase : A Framework For Multi-Product Adoption Of Rapid Sterility Testing The adoption of rapid sterility testing... 3 months ago | 120 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 ... 3 months ago | 88 mins Characterization of Residual Impurities in Gene Therapy Drug Products Jessica Townsend, Senior Manager Analytical Development at bluebird bio Characterization of residual impurities for gene therapy drug products is particularly challenging due to the complex nature of the final products as ... January 26, 2023 3:00pm Load more
