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.
One of the most significant changes to the pharmaceutical industry in the last decade has been the increased speed in developing new therapies. A striking example of this is the rapid rollout of the COVID-19 vaccines. What usually took 10-15 years was researched, developed, and put into production...
Biocon Biologics is one of the 2021 Facility of the Year Awards Winner for the 2021 Facility of the Year Honorable Mention Award for their Biocon Biologics Manufacturing (B3) project in Bangalore, India.
ICH Q10 outlines three objectives: achieve product realization, establish and maintain a state of control, and facilitate continual improvement. Embracing these objectives can be best achieved using the dual enablers, Knowledge Management (KM) and Quality Risk Management (QRM). The pharmaceutical...