This webcast features: Sameer Kalghatgi, PhD, Director of Molecular Biology, WuXi Advanced Therapies. Genetic stability and identity testing are necessary for novel cell and gene therapies to achieve regulatory approval. Sanger Sequencing, human cell line identification using short tandem repeats (STRs) and next generation sequencing (NGS), are important tools for identity and stability testing but must be implemented in a reproducible way. For regulatory approval, the identity and stability of transfected DNA inserts must be confirmed. Sanger Sequencing is widely…

This webcast features: Geddy Hamblen, Field Applications Scientist, Mirus Bio. As demand for viral vectors has grown in recent years, larger production scales are increasingly common. As processes scale, transient transfection must also scale to match. The VirusGEN® family of transfection products, developed by Mirus Bio, has been used successfully at scale in clinical manufacturing and brings unique advantages leading to higher titers and a more robust manufacturing process. In this webinar we will discuss: Challenges and solutions for transfection…

This webcast features: Andres Castillo, Portfolio Manager, Sartorius & Shanya Jiang, PhD, Portfolio Manager, Sartorius. Viral-based therapies like gene therapy or vaccine development require broad and thorough process screening before transitioning into optimization. Screening sets the stage to choose the best performing media, key parameters, and cell lines with minimal variability before optimizing the critical process parameters (CPPs) and critical quality attributes (CQAs). In this 15 minute webcast, Andres Castillo and Shanya Jiang, PhD from Sartorius present an automated and…

This webcast features: Kyle Deluca, Senior Scientist, Engineering & Felix Milman, Specialist, Engineering, Merck. In an effort to improve the efficiency of large molecule process characterization work, the Bioconjugation and Chemistry Commercialization team at Merck looked to automate steps involved in the production of its vaccine pipeline candidates. The actions taken by the team included installation of an automated reactor system that would provide new process capability and allow reactions to be completed outside of business hours, while improving process…

This webcast features: Kajal Brahmbhatt, Director of QC Analytical Services, WuXi Advanced Therapies. Mycoplasma bacteria frequently and easily contaminates cell cultures and can have devastating effects on the manufacture of cell and gene therapies. To avoid extensive destruction of product batches and delayed provision of treatment to patients, it is critical that robust mycoplasma testing processes are implemented. In this webinar, learn best practices for mycoplasma testing, helping innovators to plan their strategy for cell and gene therapy development. Key…