FDA approves manufacturing process for active ingredient, rhPDGF-BB.
The FDA completed its evaluation and approval of the manufacturing facility that produces rhPDGF-BB, the key active ingredient in BioMimetic Therapeutics’ lead product, GEM 21S, Growth-factor Enhanced Matrix.
“This approval will expand the availability of rhPDGF-BB inventory insuring the company’s ability to meet the demands for commercial supply of GEM 21S,” points out Samuel E. Lynch, president and CEO. GEM 21S is marketed for the treatment of periodontal bone defects and gingival recession. GEM OS1, which also uses rhPDGF-BB, is currently being evaluated in three clinical trials for orthopedic indications.
As part of the approval process of GEM 21S, the FDA required the review and approval of a manufacturing site owned and operated by Novartis in Vacaville, CA, which manufactures bulk supply of rhPDGF-BB.
In addition, the two other FDA conditions as part of the post-approval requirements for GEM 21S were also been met. These included the establishment of a new analytical test for the identification of rhPDGF-BB in bulk production lots and the submission of characterization data to the FDA for lots of rhPDGF-BB manufactured through August 2006.