Author Archives: BPI Contributor

Product Robustness, Integrity Testing Science and Technologies for Enhanced Process Integrity and Patient Safety

This webcast features: Carole Langlois, Marketing Manager, Traditional Vaccines, and Marc Hogreve, Senior Engineer Integrity Testing, at Sartorius Stedim Biotech With the expansion of Single Use Systems (SUS) in all process steps of commercial manufacturing, integrity failure can significantly impact drug safety, availability and costs. Consequently, there is an increasing industry scrutiny on single-use container closure integrity (SU CCI), raising the need to develop good science behind liquid leakage and microbial ingress and appropriate physical integrity testing technologies. The presenters…

MYCAP CCX flask cap

Transform Cell Expansion: Expand Outside the Hood

This webcast features: Charles Meadows, Head of Product Management, Smart Consumables, Sartorius-Stedim Biotech Cell Culture expansion from vial to seed bioreactor is done by passaging culture through successively larger Erlenmeyer shake flasks. Sampling, media feed, inoculation and transfers are done non-aseptically by unscrewing the cap in a biosafety cabinet (BSC). Contaminated expansions due to non-aseptic technique are abandoned costing time and materials. Sartorius leveraged novel bottle closure manufacturing technology to create MYCAP® CCX. MYCAP® CCX combines tubing for aseptic fluid…

China’s Investments and Licensing Deals

This webcast features: Dr. Linda Pullan, Founder, Pullan Consulting China’s biopharmaceutical industry is continuing its growth momentum. This robust growth is boosted by continuous investment into the sector. A clear strategic indicator of the government’s intentions in biopharma and biologics has been the China’s investment in biopharma industrial hubs, which will have added more than USD $300 billion to the biological industry nationwide by 2020. In Part 2 of our series, Dr. Linda Pullan, Principal, Pullan Consulting, covers China investments,…

Manufacturing Considerations for Virus Filtration Processes Using Planova BioEX

This webcast features: Parag Patel, Senior Regional Manager, Asahi Kasei Bioprocess Viral clearance of biopharmaceutical- and plasma-derived therapeutics is an important regulatory requirement that ensures patient safety.  Although there are many viral clearance strategies and technologies that can be deployed, size exclusion filtration remains the gold standard in virus removal. Virus filtration by size exclusion is a robust method for removing virus without impacting the efficacy of the final drug product.  We will take you through the steps of developing…

Developability: Evaluating Specificity, Immunogenicity, Functionality, and Manufacturability for Lead Candidate Selection

This webcast features: Campbell Bunce, Chief Scientific Officer, Abzena Developability assessment is based on multiple readouts that capture the fundamental characteristics of successful drug design: specificity, functionality, safety and manufacturability. Developability assessment can severely reduce the time and expenditure required to take multiple lead candidates through expensive cell line development and manufacturing runs when the molecule has inherent liabilities that will inhibit its progress. Why do it: Identify liabilities and risk factors in drug candidates early in the development process…

A New AEX Mixed-Mode Chromatography Resin for High Selectivity and Recovery

This webcast features: Dr. Xuemei He, R&D Manager, Chromatography Media Chemistry, Bio-Rad Laboratories Biomolecules are becoming more diversified and complex. Bio-Rad’s newest hydrophobic AEX chromatography resin, Nuvia aPrime 4A, is engineered with distinct balance of ligand density and hydrophobicity. In this webinar, Dr. Xuemei He will introduce the properties of Nuvia aPrime 4A Resin. This mixed-mode resin is designed to facilitate selective and reversible binding of target molecules for higher purity and recovery over traditional chromatography resins. Case studies will…

The Proper Use of Extractables Data: Aspects Beyond Extractables Measurement

This webcast features: Dr. Armin Hauk, Lead Scientist, and Jean-Marc Cappia, Head of Segment Marketing Vaccines, at Sartorius Stedim Biotech The implementation and use of single-use system (SUS) in biopharmaceutical production is rapidly increasing and directly correlated with higher demands on Extractables and Leachables (E&L) information. Sartorius as a leader in SUS technology can look back on +20 years of experiences in the E&L area. This knowledge together with our current research initiatives enables us to progress and go beyond…

Automating Workflow Solutions, Not Instruments: Engineering Validated Processes for Biologics Screening

This webcast features: Brian Bordeau, Business Development, Global Advanced Workflows and Engineered Solutions Automation can be a lifeline for scientists working in the discovery and development of biologics. The prospects for increasing sample throughput, reducing operator time, and streamlining data audit trails are alluring. However, at the same time, introducing automation can be a frightening and confusing project, with efforts often falling short of expectations for lack of bigger picture thinking. The Advanced Workflow Engineering Solutions (AWES) team at Molecular…

China Biopharma Opportunities

This webcast features: Michael Frizberg, President, CMAB – Switzerland and Hong Kong and Eric Langer, Principal, BioPlan Associates China aspires to become one of if not the leading country contributor to the global pharmaceutical and biopharmaceutical industry by 2030. Large companies in this sector—both international firms expanding their own footprint within China and indigenous Chinese firms establishing both their internal and their global footprints—have witnessed double-digit growth for much of the past five to seven years. The global pharmaceutical and…

China’s Emergence in Global Biopharma Manufacturing: Trends in the Chinese Biopharma Industry

This four-part educational series, sponsored by BioProcess International and BioPlan Associates, Inc., highlights key trends emerging in China biopharmaceuticals, using select content BioPlan Associates’ 2018 2nd edition report, Advances in Biopharmaceutical Technology in China, 2nd Ed. The quarterly series, each consisting of articles, an e-book, 40-min webcast, and live presentation at select BPI Events cover China’s Emergence in Global Biopharma Manufacturing: Trends in Chinese Biopharma Industry. The projects include an Overview, Developments in Biologics, Biosimilars, and Global Expansion. The series…