Biofrontera Inc. announced 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 optimizing for scale and ensuring commercial supply without compromising quality,” stated Erica Monaco, Chief Executive Officer of Biofrontera Inc.
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