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…

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…

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…

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…

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…

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…