Webinars

Robust Methods for Stability and Identity Testing of Cell and Gene Therapies

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…

Enabling mRNA-Based Therapeutics Development Through Efficient and Scalable mRNA Purification Methods

This webcast features: Jenny England, PhD, R&D Manager, Innovation & Applications Group, Thermo Fisher Scientific. As a direct result of the COVID-19 pandemic, mRNA-based therapeutics development has made major progress. The potential of using mRNA as a therapy seems to be endless and an increasing number of indications is filling up the clinical pipeline rapidly. As the development of these therapies continues to rise, the industry is looking into efficient and scalable manufacturing techniques. To support the commercial production of…

Bioprocess Considerations for Large Scale Transfection

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 VirusGENĀ® 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…

Screen Smarter Not Harder: Expand and Accelerate Your Cell Line & Viral Vector Screening

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 webcast, Andres Castillo and Shanya Jiang, PhD from Sartorius will present an automated and data-driven…

Streamlining of Process Characterization Using an Automated Reactor System

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…

Best Practices in Mycoplasma Testing for Cell and Gene Therapies

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…

Purification of DNA Oligonucleotides Using Anion Exchange Chromatography

This webcast features: William H. Rushton, Process Chromatography Support Scientist, Bio-Rad Laboratories. DNA oligonucleotides obtained by solid-phase synthesis contain incomplete or erroneous sequences that require removal for the advancement of these molecules as therapeutics. These key impurities in crude samples are length-based and are best removed by anion exchange chromatography. In this webcast, data will be presented using Nuvia HP-Q Resin, a high-performance strong anion exchanger, used for the purification of two oligonucleotides (20-mer and 21-mer) having a phosphodiester backbone.…

Development of LentiVEX™ Packaging and Producer Cell Lines for Lentivirus Manufacture

This webcast features: Corinne Branciaroli, Group Leader, CLD Viral Manufacturing, OXGENE, a WuXi Advanced Therapies Company. Lentiviral (LV) vectors have significant potential for cell and gene therapy applications. CAR-T and TCR therapies are becoming established treatments for blood malignancies that donā€™t respond to current therapies, and novel research aims to also exploit the usage of LV vectors to target solid tumors. However, challenges remain within the LV vector manufacturing process, such as achieving scalability and robustness. These challenges contribute to…

Next Generation PATfixTM Software

This webcast features: Blaž Goričar, Process Analytics Development Manager, BIA Separations, now a Sartorius company. Process development and production of gene therapy products brings together people with different skills and specializations, hence PATfixTM software is built to address the needs and solve challenges of each. An integral part of the PATfixTM value proposition, the PATfixTM software strips away the complexity of chromatography at the day-to-day operational level, while retaining it for higher level tasks. Analytical chromatography is rapidly gaining supremacy…

A Flexible Intensified Seed Train to Boost Biopharma Productivity

This webcast features: Yuliya Mikhed, PhD, Product Manager, BiostatĀ® RM Bioreactors & Matthew Houser, Product Manager, Biostat STRĀ®, Sartorius. Biopharma manufacturers need adaptable, efficient facilities that support varied products and production demands. Process intensification (PI) and perfusion processes can help meet these challenges. In this webinar, Sartorius experts present the latest PI technologies, including advanced BiostatĀ® bioreactors integrated with PAT functionality controlled by the BiobrainĀ® automation platform. Key Takeaways: Discover BiostatĀ® RM, BiostatĀ® STR, and BiobrainĀ® automation. Explore the flexible…