Sponsored Content Archives - Page 24 of 143 - BioProcess InternationalBioProcess International

Facility Design:
A Guide to Maximizing Value

Rapid growth and changing market dynamics in biologics and vaccine sectors have prompted biopharmaceutical companies and contract development and manufacturing organizations (CDMOs) to build new manufacturing facilities at unprecedented speeds. This often means developing single-use (SU) or hybrid bioprocessing facilities with reusable legacy equipment for production of monoclonal antibodies (MAbs), antibody–drug conjugates (ADCs), and viral-based vectors. For many companies, facility design begins by engaging an engineering consultancy to develop a layout that maximizes space use and minimizes equipment, fittings, and…

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

by BPI Contributor

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…

bioCERTIFIED: Turn Your Quality Management System into a Competitive Advantage

by BPI Contributor

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…

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

by BPI Contributor

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…

Advantages of Spray-Dried Mannitol in Roll Compaction Processes

by BPI Contributor

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…

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

by BPI Contributor

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…

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

by BPI Contributor

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…

“Breez”ing the Way into Process Development with Perfusion Technology

by BPI Contributor

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…

Setting the Stage for Electronic Data Exchange

by BPI Contributor

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…

Is your cell and gene therapy manufacturing at risk for SARS-CoV-2?

by BPI Staff

New US FDA guidance recommends evaluating process and product for transmission potential.  Though respiratory viruses such as SARS-CoV-2 are not known to be transmitted by implantation, transplantation, infusion, or transfer – i.e., the common route of administration for cellular and gene therapies – there is much about the novel coronavirus that is unclear. We do know, however, that SARS-CoV-2 has been shown to infect and replicate in cells commonly used in vector production. For developers of cellular and gene therapies that use vector delivery, this…