Ask the Experts

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…

Streamlining Vaccine Process Characterization Using an Automated Reactor System

During a September 2022 webinar, Kyle Deluca (a senior scientist in engineering at Merck) highlighted bottlenecks in his group’s workflow for characterizing production of a pneumonia vaccine. In that process, purified components undergo chemical modification in a synthesis reactor, followed by buffer exchange, size-based separation, additional chemical modification, and final purification. Because the modification steps were time and labor intensive, Merck automated them. With support from Mettler Toledo, Deluca and Felix Milman (a specialist in engineering at Merck) described how…

Accelerating Early Upstream Screening Activities for Viral Vector Therapies

Biopharmaceuticals delivered by viral vectors (VVs) face distinctive obstacles during early upstream development. In October 2022, Andres Castillo (a portfolio manager at Sartorius) noted that drug makers set short development timelines to hasten therapies into the clinical evaluation. Doing so limits time for analyzing complex biointeractions, and studies for culture-media and VV screening are time- and resource-intensive. Castillo and Shanya Jiang (also a portfolio manager at Sartorius) explored how integrated technologies facilitate robust cell-line and VV screening. The Presentation Reflecting…

A Novel Membrane Technology for Robust, Scalable Antibody Capture

Biopharmaceutical manufacturers usually apply resin-based affinity- chromatography media for monoclonal-antibody (MAb) capture. Such materials are costly, and their biophysical limitations can create operational difficulties. In an October 2022 webinar, Volkmar Thom (director of membrane chromatography R&D at Sartorius) spoke about his company’s development of a “convecdiff” affinity membrane. He described how the technology can help users to intensify capture processes, reducing downstream manufacturing costs. The Presentation Protein A resins contain porous beads of 50–100 μm in diameter. MAbs must diffuse…

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…