Jason Bertola Director, Global Highly Potent & Oncology Platform CordenPharma

Jason Bertola, Director, Global Highly Potent & Oncology Platform, CordenPharma International, outlined the company’s integration of its acquisition of a former Pfizer active pharmaceutical ingredient (API) manufacturing facility and plans for further expansion at the DCAT Week ’18 Member Company Announcement Forum, which was held Monday, March 19, 2018 in New York.

In November 2017, CordenPharma acquired the 54,000-square-foot API manufacturing facility in Boulder, Colorado with more than 100 employees. The facility is now called CordenPharma Boulder. Located in proximity to the existing CordenPharma Colorado facility, the new site specializes in the development, scale-up, optimization, and production of highly potent and cytotoxic/cytostatic APIs from development quantities to commercialization.

CordenPharma Boulder has a 26-year history in working with highly potent APIs dating back to early work on paclitaxel. Its API production capabilities range from very small-scale up to 3,000 liters and include low-temperature, hydrogenation, and preparative high-performance liquid chromatography (HPLC) capabilities. All these operations at occupational exposure llimits (OELs) less than 10 ng/cubic meter.

Bertola noted that CordenPharma Boulder and CordenPharma Colorado share similar containment systems and policies to further simplify integration, and CordenPharma Boulder is now part of CordenPharma’s integrated network of facilities. He added that the acquisition of the Boulder facility is aligned with a broader corporate strategy of offering fully integrated supply (APIs, drug products, packaging, and logistics), including a broad range of expertise in the development and manufacturing of highly potent and oncology products. CordenPharma Boulder and CordenPharma Colorado manufacture high-potency APIs. CordenPharma Plankstadt (Germany) focuses on highly potent oral solid dosage formulations, and CordenPharma Latina (Italy) is focused on oncological injectables.