The Emerging Technology programme was set up to encourage the adoption of new technologies in order to modernise pharmaceutical development and manufacturing in areas were the US Food and Drug Administration (FDA) has limited review or inspection experience.
“This is technology with the potential to modernise the body of knowledge associated with pharmaceutical development to support more robust, predictable, and cost-effective processes or novel products,” Thomas O’Connor from the FDA’s Office of Pharmaceutical Quality told delegates at last week’s AAPS meeting in Denver, Colorado.
Such technology, he continued, can address underlying causes of product recalls and drug shortages, facilitate new clinical development, and improve manufacturing efficiency.
“Our vision is to have a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drugs without extensive regulatory oversight.”
Last year the Agency issued draft guidance to firms looking to participate by submitting chemistry, manufacturing, and controls (CMC) information containing emerging manufacturing as part of their IND, NDA, ANDA or BLA application.
30 requests, 2 approvals
O’Connor forms part of the Emerging technology Team (ETT), formed in 2013 to facilitate the programme and aid industry with applications, and so far this year he revealed the FDA received 20 requests to participate, doubling the number requested in 2015.
Continuous manufacturing technologies for drug product, substance and biological products represented 30% of total requests, while another 30% involved the use of robotics and container closure systems for sterile injectable production.
22% of submissions have been focused on biotechnology processes and analysis – including on demand production and multi-attribute methods – while the other 17% encompasses requests which included other areas of innovation, including new dosage forms and 3D printing.
So far, two approved products have included emerging technologies in the chemistry, manufacturing, and controls (CMC) information sections of their applications:
Aprecia Pharamceutical’s SPRITAM (levetiracetam) was the first 3D-printed drug to be approved in the US in August 2015, while in April this year the Agency approved a new continuous method of production for Janssen’s HIV drug Prezista (darunavir).