First Molecule to Complete the Development-to-Launch Cycle within PCI’s Contained Manufacturing Facility
PCI Pharma Services has announced its first client product to move from clinical development to US commercial launch.
We are proud to support Takeda Pharmaceutical Company Limited, through our wholly-owned subsidiary ARIAD Pharmaceuticals, Inc., in the development, manufacture, clinical trial supply and US commercial launch of ALUNBRIG™ (brigatinib). The launch of ALUNBRIG is a significant milestone for our contained manufacturing facility, whose doors to this purpose-built site opened in late 2013. We now run multiple projects within this contained facility, and expects a high percentage of these to achieve regulatory approval and commercial launch in markets around the world.
ALUNBRIG, a once-daily tablet, is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Takeda chose to partner with us for our specialist team of formulation scientists and state-of-the-art facility at Tredegar, benefiting from its cutting-edge service for the processing of highly potent molecules. PCI’s ability to safely process molecules with an Occupational Exposure Limit (OEL) as low as 0.01µg/m3, and fully contained engineering solutions used at the site allow the safe development and manufacturing of such molecules while eliminating the need for Personal Protective Equipment (PPE) for routine operations.
Richard Yarwood, PCI Senior Vice President, International, commented: “This is a significant milestone for our Tredegar site. When we officially launched the contained facility, it was with the intention of being able to leverage our 30 plus years’ experience and expertise to deliver a full and seamless service of development through to commercial launch for our customers.”
Yarwood continued: “The engineering solutions and geometric scale-up provided by our equipment trains ensured a smooth transition of ALUNBRIG™ through development, scale-up and ultimately commercial supply for Takeda.“