Analysis and testing showed that control systems in place at the 18,000 square foot San Diego plant are effective at controlling airborne particulates down to levels of 0.1ug per cubic metre.
Company president Tim Scott said the clearance “allows PharmaTek to expand our development and manufacturing services to include highly potent and cytotoxic compounds, and do it in the safest possible way."
He went on to say that: "The results from extensive facility testing exceeded Pharmatek's expectations for the safe handling of category 4 compounds on a 5 band scheme."
Kevin Rosenthal, head of PharmaTek’s manufacturing operations, stressed that the airboune particulate results were just part of an overall programme designed to ensure worker safety.
"Combined with the facility engineering controls, significantly lower particulate levels are achieved when respiratory protection factors and process specific enclosure systems are taken into account.”
In addition to the development space, the facility houses two certified and validated high-containment manufacturing suites designed with soft-wall enclosure systems, enabling PharmaTek to tailor production operations to a specific client’s needs.
The market for cytotoxic production looks set to continue growing over the next few years as a rise in demand for novel, potent medications to replenish pipelines coincides with Big Pharma’s efforts to cut back on internal manufacturing capacity.
While this will drive demand of all types of contract drug manufacture, the specialised handling skills needed to make cytotoxics and the investment required to develop such capacity is likely to limit the number of companies offering such services.
PharmaTek’s main US competitors in the cytotoxics market are Cytovance Biologics and SAFC, which have both increased manufacturing capacity in recent years to try and keep up with demand.
Another factor likely to drive the market for cytotoxic drugs, and hence manufacturing capacity, is the incidence of cancer worldwide, which a World Health Organization (WHO) report suggested will grow 50 per cent, to 15m new cases, by 2020.