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:
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.
As with all aspects of our life sciences industry, understanding how we can best meet the needs of patients with the timely delivery of life saving and sustaining products is of paramount concern. During the years since the global pandemic, the expectations and pressures on the pharmaceutical industry with respect to development, speed to market, quality and sustainability have increased...
At the 2024 ISPE Europe Annual Conference, held in Lisbon, Portugal, 16-18 April, Richard L. Friedman, MS, Deputy Director of the US Food and Drug Administration’s (US FDA) Office of Manufacturing Quality, in...
Insight from Austria’s Regulatory Authority Representative
At the 2024 ISPE Aseptic Conference, held March 12-13 in Vienna, Austria, Christina Meissner, a European Union Good Manufacturing Practice (GMP) inspector at the Austrian Agency for Health and Food Safety since 2013, and Chair of the PIC/S Drafting Group on Annex 2A and 2B, published in May 2021, offered a presentation titled...