17th December 2014 - Spinnovation Analytical receives GMP certification for testing drug substances and drug products to support market release

17th December 2014 - Spinnovation Analytical receives GMP certification for testing drug substances and drug products to support market release

 

NEWS RELEASE

 Spinnovation Analytical receives GMP certification for testing drug substances and drug products to support market release

 17 December 2014: Spinnovation Analytical BV, Oss, The Netherlands: 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-NMRTM and Spedia-PredictTM.

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."

Visit www.spinnovation-analytical.com and www.spinnovation-biologics.com for more information.

End

Spedia-NMR™ and Spedia-Predict™ are registered trademarks of Spinnovation Analytical BV.

(complete press release in PDF)

About Spinnovation Analytical BV
Spinnovation Analytical is a contract research organization expert in delivering advanced analytical services to the Industry (Pharmaceuticals, Chemicals/Polymers, Food Products). Its expertise and core activity focuses on the use of Nuclear Magnetic Resonance Spectroscopy (NMR) and Mass Spectrometry (MS) to study molecules and materials. The company operates under two divisions. Spinnovation Analytical addresses the issues of the Life Science and small-molecule pharmaceutical industry, and Spinnovation Biologics focuses on delivering advanced analytical solutions to the BioPharma and Biotech industry.

As from September 2014, the company has been integrated to Sinensis Life Sciences (Leiden, The Netherlands, www.sinensislifesciences.com), an independent provider of laboratory testing and manufacturing services to the international life sciences market.

For more information:

For press information, please contact:
Emily Thurston, Kapler Communications
Phoenix House, Phoenix Park.
Eaton Socon, Cambridgeshire, PE19 8EP, UK
Tel: +44 (0)1480 471059; Fax: +44 (0)1480 471069 This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Dr. Frederic Girard, Spinnovation Analytical BV,
Molenstraat 110,
5342CC Oss, The Netherlands
Tel.: +31(0)24-240-3400, e-mail: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

 
 

Spinnovation Analytical is part of Sinensis Life Sciences

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