Significantly Improves Manufacturing Efficiency, Quality Control and Supply Reliability
WOBURN, Mass., April 13, 2022 (GLOBE NEWSWIRE) — Biofrontera Inc. BFRI, a biopharmaceutical company specializing in the commercialization of dermatological products, announced today that the U.S. Food and Drug Administration (FDA) has approved Biofrontera Pharma’s cGMP laboratory in Leverkusen, Germany, as a contract laboratory for batch control and stability testing of Ameluz® (aminolevulinic acid hydrochloride gel, 10%). This recognition enables significant improvements in product manufacturing efficiency, quality control and reliability of supply.
The FDA cleared Biofrontera Pharma GmbH’s laboratory to operate a method of impurity testing, which is a critical component of the gel’s stability assurance. The clearance enables part of the necessary testing of production batches to be performed in the Leverkusen facility, thereby reducing dependence on third-party suppliers and the risk of production downtime and product delays. Previously, quality control was conducted entirely by contract manufacturers in collaboration with third-party providers.
“Impurity testing is extremely complex and one of the most important components of batch release and stability testing. To establish such a method at third-party suppliers could take a year or two, and several contract laboratories have already failed at establishing the specific methods we need for Ameluz®. Bringing this important function under the control of our licensor therefore strengthens quality control, reduces third-party dependence and enables transparency to identify opportunities for further developments,” stated Hermann Lübbert, Executive Chairman of Biofrontera Inc.
“Under a license and supply agreement with Biofrontera AG, we have exclusive rights to market and sell Ameluz and the PDT-lamps BF-RhodoLED® and RhodoLED XL in the U.S. As our U.S. commercial sales build momentum, we appreciate the importance of…