What’s New & Highlights for the 2019 ISPE Aseptic Conference
By the year 2025, every second new biopharmaceutical product will be considered highly potent and/or toxic with the oncology sector driving the growth. Highly potent/toxic products are a new generation of combined products like antibody drug conjugates (ADCs) or cell, immune, or gene therapies found in regenerative medicine. This new generation of products demands more stringent requirements for cleaning in multi-product facilities to prevent cross-contamination and provide occupational safety for the operators.
As a member of the 2019 ISPE Aseptic Conference Program Committee, I am committed to creating a program that will address the complex issues surrounding the manufacturing of these products. We have developed a full track this year dedicated to containment, including breakout sessions and round table discussions to give you the opportunity to get your most pressing questions answered and interact with fellow aseptic industry experts.
Containment topics include:
Annex 1 and its impact on aseptic processing
Regulatory and occupational safety requirements
Flexible and automated operations
Cleaning and cross contamination
Case studies on successfully installed fill & finish operations
Case studies from:
Roche in Germany
Fresenius Kabi’s new expansion of high potent products
It’s exciting to be a part of this conference year after year! There is always new and valuable information to take back to our organizations, especially with the networking opportunities available to interact informally with other attendees and gain new insights from pharma industry experts. ISPE and its conferences have been an important part of my entire career and helped provide me with the knowledge and tools to make me an expert over the past 20 years. Check back over the next several months, as we’ll be sharing more about the 28th Annual ISPE Aseptic Conference. I look forward to seeing you there.
FDA Commissioner Stephen M. Hahn, MD, spoke about the lessons learned from COVID-19 in a presentation during the ISPE Annual Member Meeting on 5 November at the 2020 ISPE Annual Meeting & Expo. He discussed how the FDA has been responding to the pandemic, including how actions taken in response to...
2020 ISPE Europe Annual Conference This article covers a regulatory panel discussion at the virtual 2020 ISPE Annual Meeting & Expo on the topic of Distant Assessments on GMP and Inspection Reliance. Driven by digitalization, these assessments help the industry and regulators manage inspection...