Join us for a free 2-day live event on March 26 & 27, where Nelson Labs will address various aspects and challenges faced by equipment manufacturers, biopharmaceutical companies, and testing labs when qualifying Disposable Bioprocessing Equipment from a safety perspective. The event will cover a broad array of technical, scientific, and regulatory considerations that need to be considered when designing the right assessment approach for production equipment. Our event will be moderated by Carsten Worsoe, of Novo Nordisk.
The introduction of Disposable Bioprocessing Equipment in Biopharmaceutical manufacturing began over 20 years ago. Since then, significant progress has been made by equipment and system manufacturers, as well as end-users, in understanding the necessary qualifications from an Extractables/Leachables (E/L) perspective. Improved testing guidance (BPSA, BPOG, and USP<665>) has been developed, providing clearer instructions on designing, performing, and evaluating tests.
International Regulations mandate that materials of construction and manufacturing systems must not adversely affect the safety, identity, strength, quality, or purity of the Drug Product. While the symposium primarily focuses on the safety of drug products using single-use technology, other aspects of the qualification process will also be discussed.
Safety Qualification of Disposable Bioprocessing Equipment typically involves evaluating the production line through analytical data from a well-designed E/L study.
Download here the agenda.
Key learning perspectives of this event
- USP<665> becomes official in May 2026: what are the potential consequences for the Biopharmaceutical Industry?
- A systems supplier perspective and an end-user perspective
- Upstream versus downstream equipment: is there any difference in assessment and testing approaches between the two equipment types?
- The need for different sterilization modalities
- Dynamic versus static extractions
- New Modalities in Advanced Therapy Medicinal Product (ATMP): what can we learn from Cell & Gene Therapy regarding the impact of Single-Use Systems?
- Leachable Studies for bioprocessing equipment
- Risk Assessments according to USP<665>, BPOG and other regulatory guidances: evaluating the strengths and potential flaws of each assessment approach.
- Study design and analytical approaches in E/L for disposable processing equipment
- The Toxicological Risk Assessments
- Validation of filters
The first day of the event concludes with a guided tour of the Nelson Labs laboratory facility, followed by a delightful networking event.
Don’t miss out on this unique learning experience!