Author Archives: BPI Contributor

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…

Host Cell Proteins — Bench to Production Solutions

Enzyme-linked immunosorbent assays (ELISA) are commonly used in analytical chemistry. They can be used in process development for biologic therapies to detect and quantitate host cell protein (HCP) contamination. HCP can cause immunogenic responses in patients and reduce efficacy of these therapies and therefore must be removed to meet regulatory requirements. Some challenges you may run into when utilizing ELISAs are how to prepare your samples, choosing the best generic/commercial ELISA for your needs, and ensuring security of supply for…

Magnetic Agitators Score on Climate Friendliness

A major advantage of magnetically coupled agitators is the hermetic separation of the sterile vessel interior from the agitator motor. As no mechanical seal system is required, the risk of contamination entailed by such a system is avoided. There is no requirement to lubricate the seal and no need for energy-intensive pure steam condensate: a sign of the climate friendliness of magnetic mixing technology! Elimination of steam lubrication reduces CO2 footprint Steam generation requires a lot of energy, usually from…

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…

BioProcess Insider State of the Industry — December 2022 Panel Discussion

This panel discussion features: Christopher Peterson, Associate Director, Latham Biopharm Group; Jason Slingsby, Chief Business & Corporate Development Officer, Oxford Biomedica; Dr. Ger Brophy, Executive Vice President of Biopharma Production, Avantor. BioProcess Insider’s State of the Industry takes a deeper look into the recent business news affecting the biomanufacturing industry, picking apart the numbers and highlighting potential trends. With a panel of industry experts, editor Dan Stanton will discuss recent M&A in the bioprocess space, bottlenecks within the manufacturing sector,…

From Concept to Cure: Using AAV in Gene Therapy

Because viruses efficiently insert nucleic acids into host cells upon infection, they are attractive vehicles for gene delivery. In the past, many viral gene delivery agents were unsuitable for clinical applications due to their high immunogenicity and propensity to cause cancer. To bring gene therapy to the clinic, scientists now use adeno-associated viruses (AAVs) for safe and effective gene delivery. Download this ebook from Bio-Rad to learn about Techniques for developing safe and effective AAV vectors for gene therapy Characterizing…

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…

Solving Cost and Supply Challenges in Biopharma Downstream Processing

In only five years, the number of FDA approvals for monoclonal antibody (mAb) therapies has more than doubled. These therapies continue to lead resource investment as biopharmaceutical companies drive to get these innovative, life-changing therapies to market faster. Yet mAbs downstream processing — which accounts for roughly 60% of the production cost of a biologic drug — hasn’t kept up with advances in upstream processing. Much of this challenge stems from downstream processing’s need to move biological materials through a…

Leading Biopharma Uses Linkit® AX: Here are the Results

A Leading Biopharma was looking for a way to speed up their CAR-T media preparation. Their manual aliquoting process was time intensive, had a high risk of error and inaccuracy, and lacked a strategy for scaleup to a GMP environment. Sartorius developed a semi-automated media blending and aliquoting solution – the Linkit® AX Aliquoting Solution – that has been implemented and is now part of a GMP CAR-T manufacturing process. Read about how they used Linkit® AX to achieve 10x…

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)…