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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

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…

A Novel Membrane Technology for Robust, Scalable Antibody Capture

by Volkmar Thom

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…

Addressing Challenges in Analyzing Heterogeneous AAV Populations

by Svea Cheeseman, Paul Getty and Kirsty McManus

Adenoassociated virus (AAV) vectors are made from nonenveloped virus capsids that contain single-stranded DNA. As a leading delivery system for gene therapy, AAVs are in development to treat a number of genetic diseases (1). As the industry has advanced, the number of clinical trials involving such vectors has risen dramatically (2), increasing the need for effective manufacturing and quality control (QC) methods. During biomanufacturing, expressed AAV capsids can incorporate both target and host-cell DNA in a heterogeneous population. Viral capsids…

Optimizing Process Economics Across Modalities

by Mario Phillips

Today’s drug manufacturers are faced with the need to find efficiencies across a wider range of modalities than ever before, even as gaps in technology still exist. The economics of the process includes cost and time and must also consider quality and reproducibility. Working with suppliers that understand the full scope of drug development and commercialization challenges, and provide reliable, scalable solutions tailored to each unique process is critical to success. In this special report, the team from Polyplus reintroduces…