The consent decree, which came in March 2010, was proceeded by a viral contamination in one of its bioreactors that caused the company to close down the facility and spend over 150,000 people hours to decontaminate and restart production.
“We tore it apart and we decontaminated the plant and that process took about seven or eight weeks,” Christopher Murphy, VP of manufacturing at Genzyme, told attendees at BIO’s annual conference in San Diego.
Since the consent decree was issued, the company had to bring on third-party quality vendor Quantic in order to review its quality systems, as well as each and every batch record, deviation and change order, Murphy said.
Quantic found over 500 gaps in the baseline audit, including a number of standard gaps that had to be updated. However, the FDA allowed the company to continue manufacturing Cerezyme, a treatment for the rare Gaucher disease, at the Allston plant because of a potential shortage.
“This was a plant that many of the people were working there for 10-15 years – morale was definitely low, but the people in the plant were the ones that kept it together,” Murphy said, referring to when they found out about the contamination. “It was like changing the tire of a car going 60 miles per hour,” he added.
Murphy told BioPharma-Reporter.com that since the decree was issued, the FDA has not revisited the site but Quantic has provided an updated report on the site for the agency every quarter. He added that Australia’s TGA (Therapeutic Goods Association) and UK’s MHRA (Medicines and Healthcare products Regulatory Agency) have both inspected the site since the decree was issued.
The work plan initiated under the consent decree ends in March of 2016, though the company “is not out of it” then, as it’s still required to go through a certification process, FDA inspection and surveillance process by a third-party for another five years before requesting out of the consent decree.
Until then, the company will continue its remediation efforts, run the plant at contamination with 100% batch certification and contract out some of the Cerezyme work to CMOs (contract manufacturing organizations), Murphy said.
He noted that the company never confirmed the root cause of the contamination, but it likely came from an outside material. “We’ve put in a number of things to prevent [future contamination] and so far it’s been working,” he added.
“The FDA said the contamination was the final straw,” Murphy said, noting that the company’s responses were inadequate to the warning letters, a six-week inspection by US regulators and significant Form 483.
More than 8000 documents were changed, added or revised since April 2011 at the plant, which is also when Sanofi bought the company.
More recently, the company also has strengthened its production of another rare disease treatment – Fabrazyme – with an $80m downstream plant.
“By simplifying the Allston operation to focus on one product, it becomes a bit more manageable,” Murphy said.