Tuesday, 17 June 2014

FDA Supports the use of Continuous Manufacturing

MIT Symposium
Organised by CMAC (Centre for Innovative Manufacturing in Continuous Manufacturing & Crystallisation, UK) & MIT (Massachusetts Institute of Technology, USA) on the request of the FDA, the International Symposium of Continuous Manufacturing of Pharmaceuticals was a 2 day event held in Boston (20-21st May 2014).

Attended by industry leaders and technology providers, the Symposium was the ideal platform through which to discuss the potential that continuous manufacturing has to offer the pharmaceutical industry. The symposium gave the opportunity to learn from existing users of the technology in areas such as specialty, petrochemical and food manufacture as well as the pharmaceutical industry pioneers.

With discussions centred on a series of white papers, a clear take home message was that a significant amount of effort has been expended independently by various pharmaceutical companies. However, in order to drive this effort to fruition, collaboration is needed with industry wide focus on continuous manufacturing.  Key to realising the potential held by this technology is to break down the perceived barriers of implementation - one of which is frequently discussed as being ‘the regulatory hurdle’.

Speaking in her keynote address, Dr Janet Woodcock of the FDA (Head CDER) stressed that the technology has the opportunity to provide the necessary agility, flexibility, cost and quality required to provide societal benefit but there is a ‘fear that the regulators will slow down the development program’.  In her closing, Dr Woodcock advised that companies engage with the regulators along the way as the ‘FDA is supportive of continuous manufacturing’.