Gary Baker, VP of quality assurance and regulatory affairs at Ash Stevens, told us the site - which is approved to produce 12 APIs, half of which are for cancer drugs - is running at about 70 percent capacity and is two years into a 10-year “master plan” to expand process and analytic capabilities to take on new business. The plan was developed after the company acquired neighbouring property in 2010.
The FDA’s pre-approval inspection of the part of the facility that will produce Iclusig was created in a recent expansion begun about two years ago, Baker said. He added that the FDA will probably come inspect the facility again this year as the company plans to manufacture a separate cancer drug that has yet to be approved and which he was not authorized to name.
The inspection for Ariad’s drug in November 2012 by three investigators from the FDA’s Detroit district office did not involve a physical inspection of the facility, Baker said, noting the agency does not have the manpower for such inspections.
The investigators evaluated documentation specific to the drug, as well as development reports, process qualification documentation, cleaning validation, method validation, production and stability testing documents. The inspection did not result in a Form 483, Baker said, and the investigators “did have some useful recommendations.”
“As we speak, people from Ariad and Ash are going through an evaluation of the proposed process in the new area [of the facility] and will start there soon,” Baker said. “We’re going to scale up the process by a factor of five.”
The Riverview, Michigan-based facility employs 60 people and has seen about half a dozen expansions since ground was broken on the site in 1988.
Iclusig is approved for the treatment of adult patients with chronic, accelerated or blast phase chronic myeloid leukemia that is resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior TKI therapy.
Baker said the difficulty of manufacturing Iclusig is comparable to the other cancer drug APIs made at the site, noting certain challenging aspects of the compound’s chemistry.