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.
Through the ISPE Foundation Professional Development Grant program, Silas Tamufor attended the 2023 ISPE Annual Meeting & Expo in October 2023. Tamufor is a PhD student and ISPE Boston Chapter member who began serving as the ISPE Boston Educational Programs Committee Chair in December 2023. He, along with 87 other students and recent graduates, attended the conference thanks to the...
To meet the biopharmaceutical industry’s duty to manufacture safe and effective therapies for patients, a robust quality system is fundamental to success. A quality system should link to quality culture and prioritize focusing on quality, led by management, that fosters sustainable compliance and consistent production of high-quality drugs. Strong quality culture attributes include a proactive...
Stability sampling and testing are key to ensuring that products maintain safety, identity, strength, purity, and quality throughout their claimed shelf life. It is also a regulatory requirement per ICH Q5. However, storing product samples in different environmental conditions, testing those samples for three to five years (or more) after initial manufacture, and properly analyzing and...