Why Change Is Inevitable In Aseptic Manufacturing

Sergio Mauri, Manager, Integrated Projects, Fedegari Group
Chrissie Fuchs, Fedegari Group

Aside from the usual challenges of traditional blockbuster drugs, on which patents provided a crucial period of exclusivity and protection, the new era of the pharmaceutical industry has been facing expiring patents and a consequent increase in R&D expenditure addressing also a rapidly growing demand for anti-cancer drugs. The largest number of ongoing clinical studies focus on cancer treatments and half of the newly developed anti-cancer drugs are injectable. Additionally, bio-pharma research is generating new higher value/lower volume drugs, many of which are highly ac-tive.

The key drivers for 2020 are related to high value niche therapies and personalized drugs that will require smaller batches, shorter runs, process flexibility and greater process complexity. Increasing quality expectations in this more volatile demand are expected to drive the market towards lower risks, shorter time to market and increased cost-effectiveness.