Relief Therapeutics awarded approval from Swissmedic for new GMP-compliant laboratory
James Spargo | May 15, 2023 | News story | Research and Development | GMP, Relief Therapeutics, Swissmedic, laboratory
Swiss biopharmaceutical company Relief Therapeutics has announced that its state-of-the-art R&D laboratory in Balerna, Switzerland, has been audited and approved by the Swiss Agency for Therapeutic Products (Swissmedic) and that the lab meets Good Manufacturing Practice (GMP).
The lab is run by Relief Therapeutics’ subsidiary APR Applied Pharma Research SA (APR). It offers a range of analytical and development services for internal projects while providing clients with data and full documentation to meet current Good Manufacturing Practice (cGMP), International Council for Harmonization (ICH) and international regulatory requirements.
The space includes four new high-performance liquid chromatography (HPLC) systems, analytical scales, viscometers and physical testing instruments, as well as a new packaging area containing filling and blistering machines to pack R&D prototypes.
Paolo Galfetti, chief operating officer of Relief Therapeutics and CEO of APR, stated: “GMP compliance is a critical achievement for our laboratory, enabling us to create, safeguard and supply high-quality products to patients and healthcare providers as well as enable the future submissions of product files to regulatory authorities. Our new GMP lab is designed to meet forthcoming pharmaceutical challenges and is fully integrated with the current technical and analytical R&D capabilities, with more than 800m2 equipped for analytical and formulation development of solid and non-solid dosage forms.”
Jack Weinstein, CEO of Relief Therapeutics, commented: “We are excited that our new GMP-compliant lab in Balerna, where innovation is driven by our experienced and highly talented employees, is now Swissmedic-approved and operational. APR is a trusted and experienced formulator and developer, which has been validated by the breadth and quality of its contract service partners and products that have been developed over more than 30 years.”
James Spargo
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