The 18,000 sq. ft. facility includes newly constructed analytical and formulation development laboratories and cGMP manufacturing suites dedicated to the development of highly-potent and cytotoxic drug products for early phase clinical trials.
The value of the cytotoxic (anti-cancer) drug market - still the largest category in the high-potency pharmaceutical sector - is around $10bn in the seven largest pharmaceutical markets, and CMOs have been steadily adding capacity to tap into this potential.
For example, Cambrex recently commissioned new labs in Iowa to support its high-potency activities, Patheon announced a few weeks back that it would update its plant in Manati , Puerto Rico, to provide contract manufacturing of high-potency drugs, and just this month SAFC opened a new facility for highly-potent active pharmaceutical ingredients in Madison, Wisconsin.
The reason for the investment lies with the fact that high-potency has high barriers to entry and highly-specialised requirements, particularly in terms of containment, contamination prevention and operator safety.
As a result, CMOs in the US and Europe have increasingly been moving into specialised areas such as high-potency because, at least for the moment, there is less competition from fast-developing pharmaceutical markets such as Asia and eastern Europe.
It has been estimated that eventually 65 per cent of cytotoxic manufacturing will be outsourced, compared to only 30 per cent of non-cytotoxic products.
Pharmatek can now offer analytical method development, pre-formulation testing, formulation development, manufacturing for early phase clinical trials, release testing, and stability testing and storage.
“Highly-potent and cytotoxic compounds are among the most sensitive drugs to handle and produce,” commented Kevin Rosenthal, director of manufacturing of Pharmatek.
“Our primary goal when designing the facility was to optimize product quality while ensuring operator safety to guarantee our clients’ drug candidates move smoothly from discovery to clinical trials.”
Cancer drugs are still driving the high-potency sector - growth in 2007 was around 16 per cent, well ahead of the average of 6 per cent across as a whole sector – with monoclonal antibodies and antibody conjugate drugs (ADCs) providing the biggest push. Other drugs classed as highly-potent according to their occupational exposure limits include opioids, some hormonal agents and prostaglandins.
Pharmatek’s new facility holds a State of California Food and Drug Branch (FDB) Drug Manufacturers License and is already working on a number of highly-potent development projects. The FDB license authorises Pharmatek to manufacture and ship clinical material.