AMRI says troubled Burlington plant back on track
pharmafile | July 24, 2013 | News story | Manufacturing and Production |Â Â AMRI, FDA, GMPÂ
It looks like contract research and manufacturing organisation AMRI can put the quality problems at its facility in Burlington behind it after a re-inspection by the FDA.
The plant has been under a heightened level of scrutiny after an FDA inspection in 2010 revealed a number of Good Manufacturing Practice (GMP) deviations, including particulate matter contamination in sterile injectable products and a failure to follow written procedures designed to prevent microbiological contamination.
An inspection by the agency earlier this month which focused specifically on the problems revealed in its earlier visit did lead the agency to issue another Form 483, although AMRI stressed that the three observations it noted were ‘limited in scope and nature’.
The company said it was preparing a response to the Form 483 which will detail corrective actions at Burlington, which focuses on aseptic fill-and-finish and lyophilisation activities, with the aim of allowing the warning letter to be closed out.
That will be a relief for AMRI’s investors which have seen revenues at Burlington decline from $16 million in 2010, when the CMO acquired the unit from Hyaluron – to around $5 million a year at present.
AMRI’s chief executive Thomas D’Ambra said recently the company is sufficiently encouraged by the remediation programme at Burlington that it intends to expand the unit during the course of 2013. He noted the site was audited and approved 13 times by potential customers over the course of 2012, including two big pharmaceutical companies, one of which has already re-approved AMRI as a contractor.
“Burlington continues to make progress in growing its business and the pipeline of potential deal flow continues to build,” he said during the company’s first-quarter results call, noting the plant is a critical element in AMRI’s large-scale manufacturing (LSM) operations.
LSM accounted for $26 million out of AMRI’s total first quarter revenues of $46 million, with the remainder taken up by its discovery, drug development and small-scale manufacturing operations. The company’s biggest customer in the LSM segment is GE Healthcare, which currently makes up almost a third of the division’s turnover.
Phil Taylor
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