When contract development and manufacturer Albany Molecular Research ($AMRI) bought out Hyaluron in 2010, it picked up a headache in the process. The FDA found significant problems at the former Hyaluron plant in Burlington, MA, and issued it a warning letter. That was then.
This is now. AMRI CFO Michael Nolan says improvements there have turned the operation around. He told in-PharmaTechnologist.com that a 9% jump in revenue last year and projections for 14% growth in large-scale manufacturing next year are, in part, due to the plant it once called a "money pit."
CEO Thomas E. D'Ambra said in a conference call that a final sign-off on the upgrades has yet to be made by the FDA, but that it is up and running and serving customers. According to in-PharmaTechnologist.com, D'Ambra told investors, "The Burlington site was audited by prospective customers 13 times during 2012, including by two different large pharmaceutical companies and was approved as a supplier every time."
The Hyaluron plant's specialization in aseptic fill services for liquid and lyophilized products was one factor that attracted AMRI to the facility. But in its warning letter, the FDA had criticized the plant for failing to not thoroughly investigate particulate contamination in several lots of injectable drugs. It said inspectors saw manufacturing technicians "stabbing at stoppers with the blade end of a scalpel to move them." Besides upgrades, AMRI also brought in new management to oversee quality at the facility that is now seen as key asset.
- read the in-PharmaTechnologist.com story
- FDA's 2010 warning letter