As part of the program, the company recently expanded it facility with two cGMP manufacturing suites designed specifically for API-in-capsule productions, and features humidity control and inert gas systems designed to contribute to a more robust manufacturing process.
The company has also implemented operational systems, including dedicated project teams, streamlined batch records, extended shift operations, redundant equipment and change parts, and on-demand inventory management.
“We have seen more and more clients push the envelope on how far they will take API-in-capsule in development. No longer is the technology seen as a Phase I-only solution,” said Pharmatek president Tim Scott. “And because micro-dose systems are not keeping up with the scale required for larger batches, we looked for ways to improve efficiencies, both in terms of reducing costs and speeding up processes.”
"By implementing the new API-in-capsule program, Pharmatek has increased capsule throughput and reduced production times by as much as 50%,” said Pharmatek director of manufacturing, Kevin Rosenthal. “Additionally, the program has enabled Pharmatek to lower the overall cost of API-in-capsule productions and pass substantial savings on to our clients.”