Manufacturing

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Discover Capsugel Dry-Powder Inhalation Capsule Portfolio

This webcast features: Claire Tardy, Ph.D., Research & Development Manager, Capsule Delivery Solutions, Lonza Pharma & Biotech Dry-powder inhalation (DPI) is a major drug delivery technology for the treatment of respiratory diseases and increasingly for systemic drug delivery. Providing a uniform dose in a portable, easy-to-use system, capsule-based DPI is a simple and cost-effective way to deliver medication via the pulmonary route. Within dry-powder inhalation application fields, Lonza offers the Capsugel® Zephyr™ Dry-Powder Inhalation portfolio: high-quality capsule solutions based on…

Aseptic Filling for Gene Therapies and Next-Generation Biologics Within Closed Robotic Workcells

This webcast features: Thomas Page, Ph.D, Vice President, Engineering and Asset Development, FUJIFILM Diosynth Biotechnologies Fujifilm Diosynth Biotechnologies (FDB) sought to “close the loop” by keeping all upstream and downstream aseptic processing operations within closed systems. The missing part was downstream, where FDB implemented a closed robotic filling workcell for manufacturing gene therapies. Workcells solve long-standing problems with sterility assurance, containment, and process control in aseptic filling. The knowledge developed by FDB during its implementation and early use of a…

Accelerating Development and Manufacturing Platforms for Viral Vectors

This webcast features: Bai-wei Gu, Head of the Cell Line Development Group, WuXi Advanced Therapies Developing innovative advanced therapies is one of our greatest opportunities to dramatically improve patients’ lives. In this webinar, we will discuss our recent technical advancements in efficient viral vector manufacturing process development. From cell line development, to suspension culture of HEK293 cells, to media optimization and purification process, a series of improvements were implemented to advance our platform development for scalable large-scale manufacturing of viral…

Bioprocessing Challenges and CMO Opportunities in China

This webcast features: Scott Wheelwright, PhD, Co-Founder and Principal, Complya Asia China’s biopharmaceutical manufacturing is significantly increasing, among domestic and international companies. Contract manufacturing services as well as those with potential to do so are rapidly changing as well. In Part 4 of our series, Dr. Scott Wheelwright, Co-Founder and Principal, Complya Asia, will provide an overview of factors affecting manufacturing, manufacturing trends by market, biopharmaceutical manufacturing in China among CMOs and developing companies. Just fill out the form below…

Systems Compliance: A Risk-Based Approach to Software Management

This webcast features: Martin Laferriere, Director, IT Systems Compliance, Avid Bioservices Software systems risk management and evaluations should be part of your validation process. It is possible to reduce testing by documenting your risk, actual use, regulation impact, evaluating vendor(s), etc. The approach to managing the risk evolves through audits and prior experience and can tailor the management and approach to system quality within each organizations. In my experience and observations, an efficient system risk management is essential, and it…

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

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

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

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

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…