This webcast features: Nigel Shipston, Director, Program Design, FUJIFILM Diosynth Biotechnologies A strategy for the development and scale of bioprocesses should be assessed at the earliest of stages. There are different challenges depending on the molecule and expression system. This webinar is designed to address some of the areas of consideration for successful development of bioprocesses for biologics and gene therapies. At the end of this webinar, you will be able to do a self-assessment to answer some critical questions:…

This webcast features: Dr. Sherry Parker, Senior Director, Regulatory Toxicology and Technical Services, WuXi AppTec Extractable and leachable studies of single- and multi-use manufacturing components should be followed up with a chemical safety assessment to understand the chemical risks based on the toxicity of the chemical, the dose and the exposure duration of the drug product, and the patient population for its intended use. This case study will illustrate considerations when conducting a chemical safety assessment, the pitfalls of having…

This webcast features: Claire Tardy, PhD, 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…

This webcast features: Thomas Page, PhD, 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…