Author Archives: BPI Contributor

Early Selection of Optimal Clones Made Easy: A New, High-Throughput, All-in-One Solution for Mannose Glycans Screening and Assessment of Critical Quality Attributes

by

Glycosylation is a critical quality attribute (CQA) and imparts properties such as stability, folding, solubility, cell-cell interaction and adhesion to proteins. Antibody glycosylation for example is critical due to the role carbohydrates play in modulating effector functions which affect safety and efficacy of therapeutic antibodies. The NEW Octet® GlyM Kit is designed to provide cell line development and upstream bioprocessing Octet® users with a ready to use kit for the rapid screening of % mannose content of purified and cell…

May 25, 2021

Ask the Expert: Formulation Strategies for AAV-Based Gene Therapies

by

Although formulation and drug-product activities are critical to developing gene therapies, much remains to be learned about their degradation mechanisms, and firm criteria still need to be established for buffer and excipient selection. Sarathi Vijay Boddapati (associate director of formulation and drug development at Catalent Cell and Gene Therapy) joined BPI on 25 March 2021 to present what his company continues to learn about formulating gene therapies by adapting methods used for other biologics. Boddapati’s Presentation Adenoassociated virus (AAV) remains…

May 21, 2021

bioCERTIFIED: Turn Your Quality Management System into a Competitive Advantage

by

This webcast features: Jigisha Patel, VP of Regulatory Compliance & Technical Services, Spectrum Chemical Mfg. Corp. What can go wrong will go wrong—unless you eliminate unpredictability that results in reworks, rising costs, nonconformance, and unreliable product performance. Learn how to implement quality management systems throughout your entire supply chain and help accelerate biopharmaceutical development and production time for first-mover advantages. Whether it’s upstream or downstream processing, you will gain new insight that enables you to eliminate unpredictability and batch-to-batch variability…

May 19, 2021

Ensuring Viral Safety in Cell & Gene Therapy Through Next-Generation Sequencing

by

This webcast features: Horst Ruppach, Senior Scientific and Portfolio Director, Global Biologics, Charles River The viral contamination risk of cell and gene therapy products is significant. Multiple factors open the windows for viruses to enter the process. The current viral risk mitigation strategies have limitations and can either not be applied or have limitations to cover a broader range of potential viral contaminants. One of the most important entry points to monitor are the cells. They are used to produce…

May 13, 2021

Advantages of Spray-Dried Mannitol in Roll Compaction Processes

by

Granulation steps as wet granulation are applied before the final step of tableting in order to achieve content uniformity, flowability and compressibility. Wet granulation applies water and therefore needs a drying step. To omit this for reasons of cost and API stability dry granulation or roller compaction is a compromise to achieve the desired content uniformity without having water involved and a subsequent drying step. Studies available in literature mostly focus on the use of MCC and lactose in this…

May 10, 2021

Key Considerations for Maximizing LV and AAV Production in Transient Transfection Workflows

by

This webcast features: Leisha Kopp, Applications Scientist, Mirus Bio Recombinant adenoassociated virus (AAV) and lentivirus (LV) are critical components of gene and cell therapies, which show incredible promise for the treatment of disease. Accordingly, the need for large-scale manufacture of safe and effective viral vectors has never been greater. Here, we present: Optimization strategies for AAV and LV generation in both adherent and suspension HEK 293 cells LV and AAV enhancers that further increase functional virus titers over previously optimized…

May 7, 2021

Is Fiber-Based Protein A Chromatography the Missing Piece in Single-Use mAb Purification?

by

Protein A chromatography resins are widely used for therapeutic antibody production because they perform well, giving excellent recovery and purity. But resin-based chromatography methods are better suited to large-scale manufacture. In clinical monoclonal antibody (mAb) purification, batch sizes are small, so protein A resins are rarely used to their full lifetime potential. As a result, protein A resins may be cost-prohibitive, especially for mAb manufacturing when doses are very low or where target patient populations are small. Protein A resins…

May 7, 2021

“Breezâ€ing the Way into Process Development with Perfusion Technology

by

This webcast features: Kevin Lee, Co-Founder, Principal Scientist, Erbi Biosystems The priority of speed to market is often at odds with issues around development resources, facility space, and infrastructure for both development and manufacturing. Continuous bioprocessing provides solutions for many of these challenges in certain applications, but to deliver on this promise we need fit-for-purpose tools and technologies to enable process development and provide reliable transfer to commercial manufacturing. The migration to continuous processes in process development is further hindered…

May 4, 2021

Setting the Stage for Electronic Data Exchange

by

Every day, drug manufacturers must consider and address a wide range of challenges and prospects including complex regulatory requirements, intense cost pressures and the business opportunities offered by novel product classes. Transforming biopharmaceutical manufacturing with integration of intensified, continuous, predictive and autonomous operations is one solution that holds promise for streamlining operations, exploring new therapeutic modalities and meeting regulatory expectations which continue to evolve. Digitization and automation, key elements of Bioprocessing 4.0, will be essential for this transformation, in which…

May 4, 2021

Automation of a Next-Generation Sequencing Method for Cell Line Species Identity

by

This webcast features: Dr. Christine Mitchell, Scientific Fellow, Analytical Development, WuXi Advanced Therapies As the gene and cell therapy market continues to expand, affordability and accelerated turnaround time (TAT) become increasingly important in the industry. Despite the escalating diversity of therapeutic modalities, the criticality of a robust cell bank remains a pivotal starting point for many biological products. The integrity of species identity for cell lines is a critical quality attribute for many cell and gene therapies, and with regulatory…

April 30, 2021