Webinars

Benefits of Real-Time Analytics to Overcome Common Cell Culture Challenges

This webcast features: Nick Randall, Bioprocessing Product Manager, 908 Devices. Faster development cycles, intensified processes, and automation of process control are key initiatives in biotherapeutics manufacturing. However, offline analytics requiring manual intervention are commonly used to monitor critical and time-sensitive process parameters. We describe a new automated approach for optimal growth and production, leveraging sensitive, on-line (sample-free) monitoring of glucose and lactate with automated feed control, and its impact on growth/viability, lower toxic metabolite, and improved PQA. Key takeaways: Explore…

Simplify Residual DNA Quantitation in Viral Vector Production With qPCR and dPCR Tools

This webcast features: Jonas Buege, Senior Product Manager, Pharma Analytics, Thermo Fisher Scientific. Amongst the challenges for clinical grade viral vector production is the removal of residual DNA impurities from the final drug product. Unlike traditional biologics, undesirable copackaging of residual host cell DNA as well as plasmid DNA in the viral vector capsid can lead to elevated quantities. Regulatory scrutiny has increased due to safey concerns of not only larger amounts, but also potential for inclusion of longer residual…

Simple In-House Mycoplasma Testing Method for Regulatory Expectations and Rapid, Confident, and Actionable Results

Mycoplasma contamination is a risk to cell-based biologics manufacturing, potentially jeopardizing patient safety and product quality. Therefore, regulatory guidance globally requires manufactures to routinely employ a validated mycoplasma detection strategy for lot-release of their drug product. Beyond meeting regulatory expectations, the implementation of an in-house mycoplasma testing method is extremely valuable, providing companies with rapid, actionable data for both lot-release and raw materials testing, saving both time and money. The introduction of live mycoplasma or live mycoplasma cultures in production…

The BARDA Industry Day Breakdown

This panel discussion features: Gary Disbrow, PhD, Director, Biomedical Advanced Research and Development Authority; Kristen Herring, PhD, Vice President, The Conafay Group; Ivan Silva, PhD, Principal Consultant, Latham BioPharm Group; Joshua Speidel, PhD, Managing Partner, Latham BioPharm Group; Brian Tse, PhD, Vice President, The Conafay Group. The BARDA Industry Day (BID) Breakdown was a webinar intended to better inform potential BARDA collaborators on the agency’s practices, intentions, and interests. Leveraging the information learned from BID 2022, The Conafay Group (TCG)…

Grow Your CDMO With the Addition of Gloveless, Robotic Aseptic Filling

This webcast features: John Harmer, Strategic Initiatives Leader, Aseptic Filling, Cytiva. Contract development manufacturing organizations (CDMOs) strive to enable clients to get their drug product to patients faster. By expanding their service offerings with aseptic filling capabilities, CDMOs can increase the number and the types of clients they serve. A gloveless, robotic system like the Cytiva SA25 Aseptic Filling Workcell or MicrocellTM Vial Filler helps enable operations to get up and running faster, improve flexibility between products and formats, and…

Residual DNA/Protein and Mycoplasma Detection in Cell and Gene Therapy Products

This webcast features: Hong Li, PhD, Director of Assay Transfer and Validation, WuXi Advanced Therapies. Process-related impurities such as host cell DNA and host cell proteins may have adverse effects on product quality and pose safety concerns for cell and gene therapeutic (CGT) products. These impurities must be removed to the lowest possible level in order to meet regulatory requirements, not only to ensure product safety, but also to help understand the capabilities of the manufacturing process. Therefore, throughout product…

Ensuring Leak-Free Performance During Tissue Container Shipping Utilizing ASTM D4991

This webcast features: Eric Isberg, Vice President, Life Sciences, Savillex. Companies in the fields of tissue engineering and cell therapy find that when standard, off-the-shelf labware containers are used to transport therapies, the container seal can fail during shipment. For a live tissue or cell sample being shipped to a hospital or clinic as part of a treatment, this can be a catastrophic failure that can lead to damaged samples, surgical delays, and poor patient outcomes. When selecting containers for…

Benefits of Hollow Fiber Filter Cell Expansion

This webcast features: Stuart Gibb, PhD, Scientific Strategy Lead, Terumo Blood and Cell Technologies. Cell therapy requires cells to be healthy and active throughout the entire manufacturing process for optimal endpoint efficacy. A key part of this process is cell expansion. The Quantum Flex hollow-fiber filter technology provides an effective cell culture environment to provide ready access to fresh media, waste removal, and gas exchange over micrometer distances and works with suspension and adherent cell culture. In this environment, we…

Flexible and Customized Approach to Lentiviral Vector Development and Manufacture Through a Well-Established Platform

This webcast features: Natalia Elizalde, PhD, Business Development/Project Management Director & Rakel Lopez de Maturana, PhD, Qualified Person/Regulatory Director, VIVEbiotech. VIVEbiotech is fully specialized in the development and GMP manufacture of lentiviral vectors along EMA and FDA requirements. Having worked for more than 35 international biotech and pharma companies since 2015, VIVEbiotech has developed its service approach in a customer-centric manner, so that all our activities are developed to satisfy the real requirements of our partners. In this webinar, VIVEbiotech…

Shaken, Not Stirred: Rocking Motion Versus Impeller Technology and What is Optimal for Cell Cultivation

This webcast features: Tobias Schenk, PhD, Product Manager, Rocking Motion Bioreactors and Consumables, Manufacturing BT Instruments, Sartorius Stedim Biotech. Cell cultivation might be a laborious process, requiring optimization at various stages to achieve the desired cell densities and satisfactory yields of the final product. Optimization steps can be undertaken by improving cell culture media and buffers, inoculation cell densities, as well as specific cultivation run parameters such as temperature, pH and DO values, or changing the duration of the run…