Pharmatek ‘roll’ out new equipment to expand GMP manufacturing capabilities
The two roller compactors - a pilot-scale Vector TFC-220 with a rate of 20kg per hour, and a Vector TFC-LAB Micro lab-scale roller compactor with a 1kg hourly rate - have been installed in Pharmatek’s facility and are ready for GMP manufacturing.
Jeff Bibbs, CEO and CSO of Pharmatek told in-PharmaTechnologist, “This expansion will allow us to work with a wider range of products, in terms of both scale and formulation needs.
“While the purchase was not made for a specific project,” he explained,” we have had clients approach us in the recent past saying they had projects they would bring to Pharmatek if we had roller compaction and dry granulation capabilities.”
With an eye to business, Pharmatek has granted client’s wishes by adding roller compaction. This, Bibbs says, will allow greater granulation and dry granulation capabilities, and will enable larger fill weights in powder-in-capsule dosage forms when used with Pharmatek’s microdose capsule filling technology.
Using the roller compactors, the California-based CRO will compress bulk powder - usually the Active Pharmaceutical Ingredient (API) plus other excipients - in between two rolling discs to increase the density of the material. “After milling this will make it easier to fill the produce into capsules or press into tablets,” explained Bibbs.
Increased tablet density
“The decision to expand our capabilities was made in order to better serve our client’s drug development needs as they transition from Phase I to Phase II,” said Bibbs.
“With the roller compactors, Pharmatek can now support a broad range of solid oral formulations that previously were not optimal or feasible using our existing wet granulation equipment due to moisture sensitivity,” he added.
Aiming to boost single-batch blending size capabilities by 36kg, Pharmatek have also added a Bosch GKF400 automated encapsulator with a rate of 23,000 capsules per hour, as well as a Korsch PH-106 instrumented tablet press which can produce 32,400 tablets every hour, and a 3 ccu. Ft. V-blender.
The Bosch encapsulator and Korsch tablet press “allow for much faster production times for clinical trial manufacture (CTM) drug products in capsule or tablet form,” boasted Bibbs.
This recent expansion proceeds Pharmatek’s scale-up last year, when the firm gained approval from the California State authorities to manufacture high potency APIs and cytotoxic compounds at the facility and installed Capsugel’s Xcelodose system, becoming the first CDMO in West Coast USA to have the equipment.
