Author Archives: BPI Contributor

Development of an IEX Purification Process for Lentiviral Vectors

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This webcast features: Sushmita Koley, PhD, Senior Scientist, Process Chromatography, Bio-Rad Laboratories. In recent years, gene therapy treatments have increased significantly requiring more efficient processes to purify and deliver these therapeutics. Lentiviral vectors (LVV) are a type of retrovirus and are an effective tool for gene delivery. In this webinar, data will be presented on a high-throughput screening strategy that was employed for LVV purification which provided high yield as well as acceptable HCP clearance. An initial high-throughput screening experiment…

Innovation of Novel Purification Strategies – A Case Study of a Clusterin Scavenger Resin

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Affinity chromatography resins employ target-specific ligands attached to a stationary phase and are commonly used to capture therapeutic entities in biologics manufacturing, reducing the number of required purification steps and increasing overall yield. A less common but powerful use of affinity purification is the removal of problematic impurities, such as host cell proteins. Both techniques require high-specificity affinity ligands with sufficient capacity, stability, and suitability for clinical manufacturing. In this webinar, we present the development of a novel scavenging resin…

Seven Steps to Build a Productive CDMO/Sponsor Relationship

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Once the hard work of selecting a capable biologics CDMO partner is complete, what does it take to build a productive CDMO/sponsor relationship? When evaluating biologics CDMOs, technical capabilities are understandably the primary selection criteria. Once critical technical fit and capacity are known, cultural compatibility becomes an essential ingredient in making the working relationship fruitful. At Bionova Scientific, we’ve built a reputation as a scientifically strong CDMO with the latest tools and infrastructure. But since our early days, we have…

May 17, 2023

Automated 32×32 Epitope Binning in a Single Assay

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The selection of lead candidates in the development of therapeutic monoclonal antibodies (mAbs) is a critical decision. Designing a mAb that exhibits all the desired biological and pharmaceutical properties is challenging, and therefore, this process is primarily empirical. The classification of monoclonal antibodies (mAbs) based on their binding behavior can be a valuable tool for selecting promising candidates for further development. Such classification often involves grouping mAbs with similar epitope binding regions, which are known to share similar biological functions.…

May 16, 2023

Rapid Discovery and Characterization of Monoclonal Antibodies Against the SARS-CoV-2 Delta Spike Protein

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The COVID-19 pandemic has led to a rapid and wide-ranging search for therapeutics to protect against and treat the illness. Besides the vaccines and antivirals that have been developed against SARS-CoV-2, a number of mAbs have been given emergency use authorization (EUA) by the FDA. Unfortunately, the neutralizing effect of mAb therapeutics can be reduced or negated by the evolution of viral variants. For this reason, the expedited discovery and development of new mAbs with neutralizing activity selective for novel…

May 5, 2023

Your Ultimate Guide to CMC Testing Support for Gene and Cell Therapy

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The development of Advanced Therapy Medicinal Products (ATMPs), such as gene and cell therapy products, has made significant progress in the treatment of many diseases, including cancer, genetic, and autoimmune disorders. With the promise to enhance treatment, greatly reduce side effects, and potentially cure many types of diseases and disorders, these therapies are in high demand, and biopharma companies are in a race to the clinic. However, these technologies are very complex in nature and are vastly different than traditional…

May 1, 2023

Cell Harvesting & Washing: Optimizing Viability and Recovery in Cell Therapy

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The cell harvesting step is of utmost importance for cell therapy manufacturers. During this step, high cell viability and recovery are important to maximize yield. Single-use, low shear closed-system centrifuges enable safe and efficient cell therapy manufacturing through the efficient recovery of viable cells. Additionally, in the production of cellular-based therapies, media and buffer are often used to remove unwanted proteins, serums, and debris prior to the eventual administration to patients or for research and treatment purposes. Download this case…

May 1, 2023

Addressing the Gassing Rate in Bioreactor Upscaling – is vvm a Reliable Parameter?

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Common approaches for the scale-up of bioreactors use the gas flow coefficient (vvm) as a criterion for volumetric flow rates. Besides being the most common decisive parameter when it comes to the scaling of the gassing rate, a defined vvm is frequently used in the context of process validation, and therefore considered essential for qualification. ZETA called the reliability of this parameter into question and evaluated the scaling competence of vvm in a study performed in the context of commissioning…

May 1, 2023

Advanced Orthogonal Methods to Fully Characterize Process Host Cell Proteins

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This webcast features: Jared Isaac, PhD, Associate Director, Chromatography and Mass Spectrometry, Cygnus Technologies. In recent years, we have learned that host cell proteins (HCP) can cause problems with respect to patient safety, drug substance (DS) stability, and DS efficacy. As such, it is more important than ever to fully understand the HCPs in your process. This webcast will focus on using advanced methods of immunoaffinity chromatography and mass spectrometry to fully characterize the host cell protein ELISA as well…

April 26, 2023

ELEVECTATM — Truly Stable and Inducible Producer Cell Line for Large Scale AAV Manufacturing

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The gene therapy industry has predominantly focused on rare diseases, but recently there has been a shift to prevalent diseases covering a much broader patient population. This is largely in hopes to drive down the cost of therapy as well as minimize the financial risks to therapy developers. With the current clinical trials pipeline being dominated by therapies for larger populations, the industry must recognize that our current manufacturing methods cannot efficiently produce the amount of material needed to treat…

April 20, 2023