Webinars

Automated, Closed-Loop, Inline Monitoring of CAR-T Cells in a Production Process

This webcast features: Jan Van Hauwermeiren, VP Sales and Marketing, Ovizio Imaging Systems Cell-based technology is a fundamental pillar of modern biotechnology. With the development of cell therapy products (CTPs), there is an increased need for robust and validated measurements for cell characterization to enable manufacturing control and a safe, high-quality product released to the patients. Our company has developed an inline, automated microscope that generates reliable viable cell counts (VCCs) without the need for active sampling, in real time…

GMP Flow Cytometry: Applications, Considerations and Challenges

This webcast features: Jamie Hall, Project Manager, Center of Excellence for Biopharmaceuticals, Intertek Pharmaceutical Services Flow cytometry is a powerful technique which can be applied to all stages of the drug development pipeline including discovery, clinical development, CMC, regulatory submission and in support of production. It allows the analysis of complex mixtures of particles, from polystyrene beads to cells. Utilizing a broad spectrum of fluorescent detectors, assays can be set up to assess multiple parameters at once and ascertain otherwise…

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…

China’s GMP Strategies: Dealing with Quality Management Issues, to Compete with the West

This webcast features: Dr. Fai Poon, President, Quacell Biotech Ltd. China’s biopharma sector faces multiple challenges in quality management, including lack of experience and talent, a rapidly changing regulatory environment, as well as cultural issues in management. In Part 3 of our series Fai Poon, President, QuaCell Biotech, Ltd., will cover China regulatory issues, a review of current challenges in biopharma quality management in China, and opportunities for progress in this field with the growing CMO platforms and the emerging…

Reliable Supply Network with the Highest Quality Performance, the Most Stringent Change Management and Built-In Business Continuity for Single-Use Supplies

This webcast features: Claudio Catallo, Head of Global Supply Chain and Optimization Network Strategy Execution for Fluid Management Technology Operations Unit at Sartorius Stedim Biotech, and Elisabeth Vachette, Head of Product Management for Bags/Mixing/Tanks within the Single Use Fluid Management Technologies Department at Sartorius Stedim Biotech Single-use system implementation is increasing at a steady rate, recognizing the huge benefit of disposable material in biotechnology processes, providing safer, greener, cheaper and more flexible drug manufacturing processes. Our unique expertise in global…

Updates to Characterization Methods for Single Use Plastic Components Used In Pharmaceutical and Biopharmaceutical Manufacturing

This webcast features: Sandi Schaible, Senior Director, Analytical Chemistry and Regulatory Toxicology, WuXi AppTec Leachables from single use systems have the potential to impact the quality and safety of your drug product. This presentation will help you understand those risks and how to evaluate them, the current options for test methods and what the future holds so that you can prepare. Key Questions Answered: Why is characterization of Single Use Systems Important? What is the Current State of Methods used…

Efficient Technology Transfer: A CDMO Perspective

This webcast features: Roy Sevilla, Senior Manager, Process Development Upstream Group, Avid Bioservices Successful technology transfer is essential to enable rapid manufacturing of biopharmaceuticals for early and late phase clinical supply. When a customer approaches Avid Bioservices to transfer an existing production process, we approach the technology transfer in a structured way involving a cross-functional team from all key functions of the company. This helps ensure the ability to understand and execute against the project requirements, mitigate risks, deliver the…

Lenti Non-Settled Suspension Harvest Clarification Process Development

This webcast features: Stephen Tottey, PhD, Associate Principal Scientist, Process and Technology Development, Wuxi Advanced Therapies and John Taylor, Process Development Scientist, MilliporeSigma. Clarification of non-settled Lenti suspension harvest can be challenging due to high level of impurities in the feed stream, physical characteristics of the vector, limited filter choices, and low recovery. A series of clarification studies led to the identification of two feasible clarification filter set up options that provide workable outcomes regarding product recovery, impurity reduction, process…

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…