The contract development and manufacturing organisation (CDMO) has manufactured clinical supplies of Imbruvica (Ibrutinib)on behalf of Pharmacyclics for more than three years, a company spokesman told Outsourcing-Pharma.com, and following approval from the US Food and Drug Administration (FDA) earlier this month, Catalent will now provide drug product capsules for commercial supply.
The drug is manufactured from Catalent’s Kansas City, Missouri, facility acquired in 2011 from Aptuit and we were told as part of continued global investment the site will see the firm “building out dedicated space to accommodate the commercial volume” from this extended partnership.
“[Kansas City] provides a wide range of fully integrated support services from formulation development and analytical testing to clinical supply services as well as clinical and commercial manufacturing for oral dose forms,” we were told and “the expansion is scheduled to be completed by the middle of 2014, and Catalent will announce further details in the near future.”
The agreement was reached after the 450,000 q ft site underwent an FDA Pre-Approval Inspection that resulted in zero observations, the company said.
In a statement Heow Tan, Chief of Technical Operations at Pharmacyclics, said: “It is important that we work with a development partner with expertise in both clinical and commercial supply as well as US and worldwide GMP regulations, to ensure reliable quality supply to patients.”
“Catalent currently employs 334 workers in Kansas City,” Outsourcing-Pharma.com was told, “and it is likely that we will increase the number of employees to accommodate this and other recently announced programmes at the site.”
Furthermore, the site has been strengthened by two other partnerships reaching regulatory approval announced in the last year. In December 2012 Exelixis’ Cometriq (cabozantinib) gained FDA approval, and a month later Aegerion’s Juxtapid (lomitapide) also got the thumbs up (and subsequently European Commission approval).