Spinnovation Receives Good Manufacturing Practices Certification
News Dec 18, 2014
Spinnovation has been granted a certification of Good Manufacturing Practices (GMP) compliance by the Dutch Health Care Inspectorate. This certifies that Spinnovation is qualified to test pharmaceutical drug substances and products for market release.
GMP certification is recognition of Spinnovation’s adherence to the highest quality management procedures and standards, and will support the company in delivering the QC testing services and analytical solutions for clients involved in the manufacturing and release of small molecule drugs and biologicals.
GMP certification will enable Spinnovation to extend its existing solutions based on its high-end analytical platform which notably includes Nuclear Magnetic Resonance (NMR), LC-MS, UPLC-MS/MS and ICP-OES.
The platform has also recently been expanded and now also includes solid-state NMR and X-ray powder diffraction (XRPD) methods, to offer polymorphism/amorphization testing of solid-state drug substance and pharmaceutical formulations.
Since 2005, Spinnovation has supported pharmaceuticals companies, CROs and CMOs in pre-clinical and clinical compound development, root-cause analysis, and QC testing. More recently, Spinnovation Biologics has also established itself as a leading provider in supporting biopharmaceutical and bioprocess development, and biologic and biosimilar characterization, through unique services such as Spedia-NMR™ and Spedia-Predict™.
GMP compliance now qualifies the company to test (bio-)pharmaceutical drug substances and drug products for release and support better commercial manufacturing, regulatory affairs and quality assurance teams. For instance, Spinnovation is currently supporting several global pharmaceutical companies in the release of a number of compounds and products such as heparin batch release by NMR.
Frederic Girard: “Spinnovation is committed to providing innovative, accurate and reliable testing services for our clients, and GMP qualification is part of meeting our client’s needs. We feel that GMP certification will help us to continue to establish ourselves as a leading analytical provider in pharmaceutical R&D and QC/QA-release. Our integration within Sinensis Life Sciences in September 2014 helps to further secure our position, as we are now part of a strong group that offers a comprehensive range of physical, chemical, biopharmaceutical, bacterial and viral testing and manufacturing capabilities.”