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Rapid and Efficient Measurement of Critical Quality Attributes and Parameters Using Octet® Bio-Layer Interferometry (BLI) Systems

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Critical quality attributes (CQAs) are defined as a physical, chemical, biological, or microbiological property or characteristics that should be within an appropriate limit, range, or distribution to ensure the desired product quality. These essential measurements include product-specific attributes such as size, charge, and glycosylation patterns as well as process-related impurities including host cell proteins and residual Protein A from chromatographic purification. CQAs must be identified early in the discovery process, reflect the target product profile of the drug candidate, and…

February 1, 2023

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

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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…

January 26, 2023

Host Cell Proteins — Bench to Production Solutions

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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…

January 23, 2023

Magnetic Agitators Score on Climate Friendliness

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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…

January 17, 2023

Improving Scalability of AAV and Lentivirus Production: Tailored Transfection Reagents Enable Large-Scale Manufacturing

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Scientific advances have increased the safety and efficacy of recombinant viral-vector technology for cell and gene therapies. In this special report, we will discuss how tailored transfection reagents improve the scalability of AAV and lentivirus production. We will also focus on the challenges of scaling up viral vector production platforms and the importance of selecting the right transfection reagent for this process to increase the titer and quality of viral production to generate more therapeutic doses per run. Fill out…

December 15, 2022

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

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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…

December 13, 2022

Ensuring Single-use Systems Integrity in Aseptic or Closed-Process Applications

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Due to their numerous benefits, single-use systems (SUS) have been increasingly implemented in biopharmaceutical processes in the past decades. Originally used in applications for the preparation and storage of buffer and media, SUS have become more and more important in the commercial production of biopharmaceuticals. Today, biopharmaceutical manufacturers use this technology in critical drug substance or drug product process steps such as formulation, bulk storage, bulk transport, and final filling of drug product. By using single-use technologies, manufacturers can reduce…

December 8, 2022

Purity by Design

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After launching Nereus LentiHERO, a game changing fit-for-purpose solution for lentiviral vector purification in 2022, Astrea Bioseparations present this end of year report with a selection of interviews, application notes, and articles. Identifying the gaps in lentiviral purification, they discuss how to increase processing efficiency, purity, and recovery of LVV particles. They also look towards the future to bring a radical change in bioprocessing for cell and gene therapies. The Nereus LentiHERO spin column is the first product in a…

December 8, 2022

From Concept to Cure: Using AAV in Gene Therapy

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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…

December 8, 2022

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

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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…

December 7, 2022