The revised EU GMP Annex 1 has placed renewed emphasis on developing a holistic approach to contamination control: leveraging barrier technologies, automation, rapid microbial methods and proactive management of airflow patterns, compelling manufacturers to rethink how aseptic systems are designed, qualified, and operated. With these evolving regulatory expectations and growing complexity in...
The journey of an ISPE Emerging Leader is one defined less by titles and more by growth, resilience, and the willingness to learn. Over the past several years, I’ve come to recognize a set of lessons that continue to guide my own path and the paths of many peers in the ISPE Emerging Leader community.
Advances in pharmaceutical regulation and pharmaceutical technology don’t always coincide. Each advancement moves on its own schedule, driven by its own unique forces. But sometimes there is a synergy, when advances in technology can help regulators to achieve their objectives and changes in regulation come at just the right time to enable a technology to be impactful. This interplay between...
Globally, there is an increase in approved advanced therapy medicinal products (ATMPs), with thousands of therapies currently in various stages of pre-clinical and clinical development.
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...
The outlook for the biopharmaceutical market is promising, with expectations that the market will double in the next 10 years, resulting in new therapies and advances in biopharmaceutical manufacturing. This doesn't sound like much at first, but if you consider how the market has developed over the last 20 years, a doubling in the next 10 years is very significant.
