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