Pfizer piggybacks PAT to real-time release

Pfizer ($PFE) is pursuing the gold promised by real-time release, a manufacturing process that uses process analytical technology data to side-step end-of-line testing. RTR promises quick payback to investments in PAT and training, says in-PharmaTechnologist.

The technology is ready, and regulators appear willing to support the shift, according to Pfizer in an FDA committee meeting. One potential holdup is whether manufacturers have the requisite control over manufacturing processes to make the shift to RTR. But incentives exist: Proponents claim savings in QC lab costs and lower throughput time via reduced inventory.

Gerry Migliaccio, Pfizer's senior VP, network performance, told the FDA the drug giant is "moving as aggressively as we can" to adopt the RTR method, the article says.

- read the story
- here's a link to the FDA meeting webcast

Suggested Articles

A biotech that worked with a nutritional products maker on the API for its clinical-stage radiation drug, is buying all of the manufacturing know-how.

Merck KGaA is selling a manufacturing site and its Allergopharma allergy drug business as it focuses on newer meds.

In a first, the FDA and Indian oversight agencies worked together to block illegal drugs from entering the U.S.