Manufacturing Archives - Page 7 of 12 - BioProcess InternationalBioProcess International

The Impact of Rapid Virus Quantification in the Development and Manufacture of Advanced Therapies

This webcast features: Antje Schickert, Product Manager, Virus Analytics, Sartorius Stedim Biotech Viral vectors, such as lenti- and adeno-associated viruses, are increasingly being used for the production of cell and gene therapies. In-depth sample characterization and precise enumeration of total viral vectors is needed throughout the manufacturing process and particularly for the final formulation. Learn how rapid accurate enumeration of the total virus provides timely information on titer leading to accelerated process development and increased efficiency of viral vector manufacturing.…

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

by BPI Contributor

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…

Navigating Regulatory Expectations for Extractables and Leachables of Combination Products

by BPI Contributor

This webcast features: Sandi Schaible, Senior Director, Analytical Chemistry and Regulatory Toxicology, WuXi AppTec The expectations for extractables and leachables of medical devices (delivery systems) are different than those of typical pharmaceutical applications such as container closure systems or single use systems. Learn about how the FDA reviews combination products and learn about testing expectations. Put these expectations to practice with a case study review complete including common pitfalls in testing. Key lessons learned: How does the FDA interact internally…

GMP Flow Cytometry: Applications, Considerations and Challenges

by BPI Contributor

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

by BPI Contributor

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

by BPI Contributor

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

by BPI Contributor

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

by BPI Contributor

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…

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

by BPI Contributor

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…

China Investments and Licensing Deals

by BPI Contributor

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,…