Press release: Ardena supports Race Oncology in manufacturing first cGMP Batch of Bisantrene Formulation
Oss, the Netherlands, 4 April 2024 – Ardena, a global CDMO that offers integrated services for drug development, has supported Race Oncology in the manufacturing of the first cGMP batch of bisantrene formulation, RC220, ensuring it meets the stringent quality standards required for IV human clinical trials. This achievement underscores the collaborative spirit between Race and Ardena, showcasing their commitment to excellence in pharmaceutical development.
Ardena was contracted by Race to manufacture the cGMP RC220 drug product to ensure that it meets the exacting standards required by major global regulatory authorities for human clinical use, including the European Medicines Agency (EMA), the US Food & Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA) (ASX Announcement: 12 July 2023).
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