SAN DIEGO, Calif. – April 24, 2014 – Pharmatek, a contract development and manufacturing organization supporting the pharmaceutical industry, today announced the launch of the Company’s new API-in-capsule manufacturing program. The initiative, designed to meet industry demand for manufacturing strategies that lower development cost, aims to shorten timelines and increase capsule throughput for API-in-capsule productions.
Pharmatek has earned a reputation as a veteran provider of API-in-capsule having manufactured more than 90 API-in-capsule batches. Filling drug directly into capsules is one of the fastest ways to enter the clinic. The approach can reduce time and financial investment at the early phases.
“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.”
A key aspect of the program is the recent facility expansion, which includes two cGMP manufacturing suites designed specifically for API-in-capsule productions. Suite features include humidity control and inert gas systems, which contribute to a more robust manufacturing process for API-in-capsule productions. In addition to the customized suites, Pharmatek has implemented operational systems to further address efficiencies, including dedicated project teams; streamlined batch records; extended shift operations; redundant equipment and change parts; and on-demand inventory management. Combined, these efforts offer clients faster scheduling, turn-around time and speed to clinic for API-in-capsule CTM productions.
“By implementing the new API-in-capsule program, Pharmatek has increased capsule throughput and reduced production times by as much as 50%,” stated 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.”Leave a reply →