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Continuity Pharma LLC Accepted into the US FDA’s Emerging Technology Program!
20 May 2020
Continuity Pharma LLC are excited to announce their acceptance into the US FDA’s Emerging Technology Program (ETP) - paving the way for rapid & robust domestic API production! Nancy Hathaway, CEO at Continuity Pharma LLC, says acceptance into the ETP ‘validates the importance of Continuity Pharma’s approach to bringing generic drug manufacturing back to the United States. It also highlights the urgency of our mission & the necessity for bringing our innovative technology online for multiple therapies as quickly as possible’ Read More.
COVID-19 further demonstrates the need for a radical overhaul of the supply chain for critical medicines, as previously highlighted by PWC in their report ‘Pharma 2020: Supplying the Future’. As a result, there is renewed activity at a Country level to realise the domestic manufacturing of critical raw materials, API precursors & API’s. Flow chemistry provides a route to the development of small, agile plants for manufacturing, often using processes that would not be conventionally considered in ‘The West’. The low hold-up volume, small footprint & increased process safety, combined with an ease of technology transfer via replication, presents opportunities to implement alternative supply chain strategies. For example, a process can be developed in one part of the world & then the hardware is replicated - deploying turn-key systems in multiple territories for local manufacturing control!
Recognising the challenges & delays that new technologies could bring when seeking regulatory approval, the US FDA established the Emerging Technology Team (ETT) in 2013 to allow industry representatives to discuss, identify & resolve potential technical / regulatory issues prior to filing a regulatory submission. The goal being to speed-up the adoption of innovative approaches to pharmaceutical product design & manufacturing, overcoming challenges with supply chains & drug shortages. To date, five Companies have secured US FDA approval for seven continuously manufactured products – six finished dosage forms & one API Read More.