The technologies pharma uses to make drugs are evolving in line with shifting industry priorities, stricter quality regulations and the ever-present drive for cost efficiency.

Loss of IP protection, data management, approvals of nice gene & cell therapies and manufacturing efficiency are today’s biggest factors driving innovation in pharma manufacturing.

Manufacturing Evolution

4 Factors Driving Innovation in Pharma Manufacturing:

  1. Loss of IP protection has increased opportunities in the generics sector, driving demand for more efficient manufacturing. Innovative firms who have switched focus to complex
    biopharma products have stimulated the development of new manufacturing technologies & facilities
  2. The management of greater amounts of data to predict process performance and output is becoming more critical as facilities become digitised. In process development activities, new tools are being deployed to develop a greater process understanding and route to process scale-up.
  3. Approvals of niche gene & cell therapies have created the challenge of adapting existing manufacturing technologies for the newer smallscale operations. The successful production of these advanced and personalised meds will depend on new effective & compliant techs.
  4. The desire for manufacturing efficiency has sparked interest in new production approaches, there is a particular demand for systems with enhanced connectivity and monitoring capacity, to further develop continuous manufacturing and improve speed to market.

QBD initiatives favoured by regulatory agencies are predicated on the availability of reliable PAT technologies and there is still a journey to take to develop such capabilities,

John Milne,
National Institute for Bioprocessing,
Research and Training