The US Food and Drug Administration (FDA) Emerging Technology Team (ETT) was formed in 2013, and last week guidance was finalised instructing how pharma companies can work in partnership with the group to aid the development of innovative manufacturing technologies involved in a regulatory submission.
To date, there have been 32 requests accepted to the programme with a total of 60 ETT initiated interactions, Jean Hu-Primmer, senior advisor for CBRN and Pandemic Influenza at FDA, told delegates at last week’s BPI Conference in Boston.
Talking as part of a session on how advanced manufacturing technologies could help improve US national security, she urged drugmakers to take advantage of the ETT team and to get in touch, even at an early stage in development.
“These guys are awesome!” she told delegates, attending as part of Biotech Week Boston. “They’ve assembled a fantastic team of cross disciplinary experts… and they will accept your submissions at a very, very early level.”
The team is intended to serve as a centralised location for external inquiries on novel technologies, providing a forum for firms to engage in dialogue with the FDA.
“If you have any innovations associated with advanced manufacturing – for example 3D printing, any sorts of continuous manufacturing technologies, novel process analytical technology [PAT], anything that you could potentially bring effective manufacturing to a higher level – they will work with you to get everything in line.”
According to the guidance, the programme is available for products reviewed by the Center for Drug Evaluationand Research (CDER), and while it states the service “does not cover products reviewed by the Center for Biologics Evaluation and Research,” Hu-Primmer said parallel talks are being set for innovative technologies in CBER products.
So far, the programme has helped three products reach approval. Aprecia Pharmaceuticals reached regulatory success with Spritam (levetiracetam), a solid oral pill to treat epileptic seizures manufactured using a three-dimensional printer, Vertex’s Orkambi as a continuous drug substance to drug product back in July 2015, and J&J’s batch-to-continuous conversion of its HIV drug Prezista approved in 2016.
Meanwhile six further projects relating to continuous manufacturing have received FDA funding since 2013:
- University of Connecticut: Continuous manufacturing of liposomal drug formulations
- Marqmetrix: Advancing continuous flow reactor technology through real time control and product isolation for improved quality assurance and consumer safety
- Rutgers/UMassLowell: Process modelling
- Rutgers C-SOP: Continuous direct compression for final dosage form manufacturing
- NJIT: Continuous thin film manufacturing
- Continuus: Continuous end-to-end manufacturing
- ChromaTan: Continuous downstream bioprocessing
CORRECTION: The original article stated the ETT programme helped two products reach approval, whereas the current total is three.