You may have noticed that our August issue is thicker than usual. Well, it’s because this issue has been specially dedicated to celebrate Pharmaceutical Technology Europe’s 25th anniversary. The past two and a half decades of charting the progress in pharmaceutical manufacturing has been an exciting journey, filled with ups and downs. The industry has witnessed a surge in mergers and acquisitions, mostly driven by the need to bridge revenue gaps caused by pharmaceutical blockbusters plunging off the patent cliff. And as Big Pharma continues to grapple with its productivity crisis, characterised by a severe drought in innovation, not to mention the weakening R&D pipelines, it looks like the stage is set for the dawning of a new era of biosimilars, particularly in Europe where the approval pathways for this class of medicines are now more clearly defined.
The European regulatory landscape for pharmaceuticals has also evolved over the years. Changing fundamentals, such as globalisation, the rise of emerging markets and the propensity for companies to outsource manufacturing activities, have created an increasingly complex pharmaceutical supply chain that is vulnerable to adulteration, cargo theft, counterfeiting and product diversion. As a result, stakeholders are under pressure to put in place measures to ensure product quality and patient safety.
With change being the only constant, we are seeing a move away from batch processing as the industry embraces continuous manufacturing. And although adoption has been slow, the overarching paradigm of quality by design and process analytical technology is now making significant inroads into pharmaceutical development. Single-use systems that eliminate cleaning validation steps and reduce the risk of cross contamination are also changing the face of bioprocessing both upstream and downstream.
To mark 25 years of tracking the pulse of the pharmaceutical industry, our editors have put together a special anniversary section, written by the industry, for the industry. Experts share their retrospective and prospective viewpoints on trends and advances in pharmaceutical manufacturing. So sit back, relax and enjoy!
About the Author
Adeline Siew, PhD
Editor of Pharmaceutical Technology Europe