Sponsored Content Archives - Page 3 of 164 - BioProcess InternationalBioProcess International

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…

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

by Marc Hogreve, Inga Reinert and Nathalie Pathier

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…

Purity by Design

by Terry Pizzie, Sujeong Yang, Ian Scanlon, Daniella Steel, Bilal S. Ahmad and Marc Hummersone

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…

From Concept to Cure: Using AAV in Gene Therapy

by BPI Contributor

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

by BPI Contributor

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

by BPI Contributor

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…

Allogeneic Cell Therapy Manufacturing: Preparing for Tomorrow’s Success

by Elena Matsa

Cell therapies are promising new drug products that treat or cure diseases that, until the past decade, had no other treatment options. Several autologous cell therapies have been approved, and their efficacy has been proven, especially in immunooncology. However, autologous therapies can present some difficulties for both developers and patients (e.g., short timelines, point-of-care drug administration). Allogeneic cell therapies are not associated with those challenges. For example, patient access to an autologous treatment can take months, time that patients with…

Tangential-Flow Filtration Process Control and Data Acquisition System for Process Development

by Mahesh Khot

PendoTECH tangential-flow filtration (TFF) process control systems have been widely adopted in the filtration community. The system’s features enable its implementation in multiple unit operations and biopharmaceutical processing applications, including ultrafiltration–diafiltration (UF–DF) of proteins, viruses, and compounds such as oligonucleotides and antibody–drug conjugates (ADCs). The control system can be used to develop process parameters for UF–DF processes that have different membrane formats (e.g., flat-sheet cassette and hollow fiber). TFF laboratory setups often are manual or semiautomated processes that use pumps,…

Streamlining Vaccine Process Characterization Using an Automated Reactor System

by Kyle Deluca and Felix Milman

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

by Andres Castillo and Shanya Jiang

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…