Compass points to excipient elimination through microfilling

Compass’ service, which can handle pouch, vial and blister filling operations with as little as 500mg of powder or 40microliters of liquid, has already attracted the attention of the industry.

Tony Fenno, Compass’ COO, said that: "We're seeing strong interest from the contract pharmaceutical packaging industry, specifically in the development new drug compounds and subsequent clinical trials​."

Fenno explained that accurate microfilling “can reduce or even eliminate the need for excipients, which can shorten drug development times by simplifying product stability tests and stability protocols​."

He went on to say that removing excipients from drug formulations could reduce start-up and shut down losses during filling operations, allowing the improved recovery of potent active pharmaceutical ingredients (APIs).

Compass’ technical officer, Mike Castaldo, added that the microfill offering was achieved through the redesign on several of the companies filling systems, as well as improvements in its metering and monitoring capability.

As the potency of APIs continues to increase the quantities used during the production drugs fall. This means that greater quantities of excipients are often included in formulations during filling to make the ingredients easier to handle.

While there is nothing inherently wrong with this approach from a safety point of view, in the current competitive climate contract packaging firms that can offer lower priced filling services by eliminating excipient costs may well have the edge over those that don’t offer microfilling.

In addition, the necessarily smaller quantities of APIs used in clinical trial are often extremely expensive to manufacture as the production process have not been scaled up. As a result any filling technique that minimises wastage is likely to be highly valued by drug developers seeking help to move drug candidates to the clinic.