Pressures on the pharma industry, and consequently their service providers, have intensified the need to lower costs and shorten the time taken to enter Phase I. To improve its capabilities in this area Pharmatek has installed Xcelodose at its site in San Diego, California, US.
Xcelodose is a precision powder micro-doser and automated encapsulator that can accurately and directly fill capsules with formulations or active pharmaceutical ingredients. The contract development and manufacturing organisation (CDMO) believes this will help business.
Jeffrey Bibbs, chief scientific officer at Pharmatek, explained that "for powder-in-capsule (PIC) applications, the Xcelodose can drastically decrease time to clinic while also lowering the cost of drug product for first-in-human trials".
This fits with Pharmatek’s goal of “always looking for ways to move our customers' drug candidates into the clinic more efficiently without compromising quality", according to Bibbs.
Pharmatek expects validation to be complete by mid-October and is scheduling Xcelodose manufacturing for November and December.
Features of Xcelodose
Capsugel, a division of Pfizer, developed Xcelodose to shorten the drug development process and now claims it is installed at almost 70 pharmas, biotechs and contract research organisations (CRO).
The system reduces the need for companies to conduct stability studies, which can be costly and time-consuming, and consequently helps users reach the Phase I decision point sooner.
Pharmatek has installed the 600S system that can fill at over 600 capsules an hour, which Capsugel claims is 10 times faster than by hand. Furthermore, the 600S automates capsule handling, continuously filling and feeding them through the system.
Doses from 100 micrograms to over 100 milligrams can be handled and the weight of each capsule is recorded, allowing traceability of samples in compliance with good manufacturing practice (GMP) requirements.