Pharmatek Laboratories has now added cytotoxic and high-potent drug development services to its list of contract pharmaceutical offerings.
The new services, which include analytical method development, pre-formulation testing, formulation development, manufacturing for early phase clinical trials, release testing, and stability testing and storage, will be conducted at a new, dedicated facility at its existing San Diego, California site. According to the firm, it has two validated and licensed class 100,000 high-containment suites designed with barrier technology for good manufacturing practice (cGMP) production of final form drug products, along with dedicated HVAC (heating, ventilation, and air conditioning) and HEPA (high efficiency particulate air) filtration systems to ensure product containment within the suites. "This expansion was driven by an increase in demand for cytotoxic and high-potent drug development and manufacturing outsourcing among our clients," said Dr Jeffrey Bibbs, CEO of Pharmatek. Indeed, the US contract chemistry development firm has been reacting to the growing demand for analytical testing services in the pharma industry of late. In April it tripled its laboratory and manufacturing space by moving its operations to the new San Diego facility. The value of the cytotoxic (anti-cancer) drug market in the seven major pharmaceutical markets is $9.6bn (€7.2bn), according to recent data, and Baxter also recently predicted that eventually 65 per cent of cytotoxic drugs will be outsourced compared to only 30 per cent of non-cytotoxic products. Pharmatek's latest focus on cytotoxic services, therefore is in line with other contract manufacturing organisations (CMOs), like DSM Pharmaceuticals, who have spotted an opportunity in the market and have been building facilities for the purpose. Earlier this year DSM's contract manufacturing Pharmaceuticals Group completed an expansion of its US manufacturing plant in Greenville, North Carolina, in order to be able to carry out aseptic sterile manufacturing of biologics and small molecules especially for clinical trials. The main focus at this facility is vial production for injectables, however, an additional feature that is being built into the site will provide the firm with a filling suite that will be able to undertake cytotoxic manufacturing for cancer drugs by the end of 2007. "A cytotoxic production line can be extremely challenging as it is very difficult to keep the facility 100 per cent sterile and clean and so not many companies have such a capability," said Korpershoek in an earlier interview with In-Pharmatechnologist.com. "Oncology drugs can have no cross-contamination whatsoever as any mix-up can be very serious for the patient." In March, British CMO NextPharma Technologies announced a €30m fundraising round, €16m of which was earmarked to be invested in expanding the company's capabilities in injectable cytotoxic manufacturing. The investment will more than double the capacity of its facility in Braine L'Alleud, Belgium which will be ready to offer this type of service to customers in North America, Europe and Japan in 2009. This cash injection came on the heels of the recent development of a sterile product development centre at the Belgian site where the company plans to manufacture clinical supplies of cytotoxic and biologic drugs, and which it indicated at the time, should be up and running in September. Meanwhile, in December last year, Baxter announced it was expanding its lyophilisation capacity at its German facility to support future growth of its contract manufacturing business for anti-cancer drugs.
"We are expanding to meet the growing demands of the cytotoxic manufacturing market," said Tom Polen, senior director of marketing for BPS said at the time.