Sponsored Content

Development of IEX Purification Process for Lentiviral Vectors

by

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

by

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…

Building the Next Generation of Cell-Line–Development Platforms

by , , and

Speed to market is a critical business driver in the biopharmaceutical industry. However, drug development success also requires building a robust process that maximizes efficiency while limiting the cost of goods. Achieving time and cost savings without compromising product quality is critical. Development of a productive and stable cell line is the foundation of an efficient and high-performing bioprocess. Cell-line development (CLD) represents some of the most resource-intensive steps within a process development pipeline. Bioprocess scientists must find a balance…

Advantages of Mixed-Mode Chromatography in Host-Cell Protein Removal

by

Monoclonal antibodies (MAbs) are the fastest-growing modality in clinical trials and more than 100 such therapies have been approved to treat diseases. But despite the modality’s success, MAb manufacturing is often contaminated by host-cell protein (HCP) by-products. Tom Valorose, senior product manager at Astrea Bioseparations, discussed how companies can reduce HCPs dramatically during MAb purification. Valorose’s Presentation Removing HCPs is an important part of MAb downstream processing. After cell harvest, scientists perform a primary capture using affinity chromatography with protein…

Seven Steps to Build a Productive CDMO/Sponsor Relationship

by

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…

Automated 32×32 Epitope Binning in a Single Assay

by

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.…

Yposkesi launches LentiSure™, LV vector production platform optimized for higher yields

by

New lentiviral (LV) platform provides CAR-T developers with more robust capacity to drive clinical development and commercial cell and gene therapy pipelines. Evry-Courcouronnes (near Paris), France, April 2023 – Yposkesi, SK pharmteco’s clinical and commercial viral vector manufacturing arm for cell and gene therapies, today announces the launch of LentiSure™, an optimized Lentiviral (LV) Vector manufacturing platform for increasing lentivirus production efficiency and robustness. Lentivirus or LV vectors are used to produce cell-based immuno-oncology therapies. Their robustness as a gene…

May 11, 2023

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

by

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

High Precision: Automated Aseptic Filling of Small Volumes

by

Market experts recommend automated filling systems for drug developers seeking to reach the next level in drug-substance management. Many companies are starting automation initiatives, which suggests an overall trend towards automated filling. The stakes are high. Increased process deviation in fluid management can lead to increased loss of valuable biopharmaceutical products. Automated and standardized aliquoting of biopharmaceutical drug substances into single-use bioprocess containers simplifies the manufacturing process while improving throughput, speed, and filling accuracy. Fill out the form below to…

May 3, 2023

Understanding Viral Clearance During Anion-Exchange Chromatography: A Novel Design of Experiments Approach

by , , , , and

Anion-exchange (AEX) chromatography is a well-established polishing step for removal of viruses and other impurities during downstream processing of biotherapeutics. Before initiating phase 1 clinical trials, a representative scaled-down model of the final process must be available for use in viral-clearance studies. At that point, however, scientists usually have no way of knowing how effective a process will be for removing viruses. In this article, scientists from Thermo Fisher Scientific and Bristol Myers Squibb (BMS) describe their efforts to define…

May 2, 2023