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Pharma Newsletters >> Eurofins Pharma Services Newsletter 14 - June 2016 >> New cGMP NMR testing capabilities

Eurofins BioPharma Product Testing introduces new cGMP NMR testing and R&D capabilities

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Frederic Girard, PhD, Managing Director, Eurofins Spinnovation Analytical,

Through Eurofins’ acquisition of Sinensis Life Sciences, Eurofins BioPharma Product Testing has added new and unique capabilities to its existing portfolio of services and solutions to support clients’ needs for FDA/EU-GMP compliant NMR QC testing, as well as for accessing the proprietary SPEDIA-NMR method for faster upstream process development of biologics. As one of five Sinensis labs, Spinnovation Analytical specialises in high-end analytical R&D and QC testing. Spinnovation Analytical, located in the Pivot Park in Oss, Netherlands, manages an advanced technology platform, including solution-state and solid-state NMRs dedicated to support the BioPharma industry. The platform operates under an EU-GMP certificate (Dutch Health Authorities) and has been successfully inspected by the US FDA.

Solutions--Spinnovation offers a differentiated set of NMR solutions to respond to a broad range of clients’ needs. First, a (400MHz) Open-Shop NMR service is made available to accommodate local clients’ demand for rapid identity and in-process control testing to support MedChem activities. Second, Spinnovation delivers cGMP compliant NMR Quality Control Testing (solution- and solid-state) for raw material and drug product release. This concerns pharmacopeia and/or internal methods related to products like heparin, poloxamers and many other polymers, and also includes identity verification and quantification of reference compounds (qNMR for %w/w). Finally, Spinnovation offers innovative and unique solutions for BioPharma companies dedicated to Biologics Upstream Process Development with its Spedia-NMR™ service for profiling cell cultures, and Spedia-Predict™ to address bioprocess performance variabilities.

Technology--The NMR platform encompasses three solutionstate NMR Avance III Bruker spectrometers (1 x 400 MHz, 2 x 500 MHz) fitted with SampleJet accessories for rapid throughput, and cryoprobe technology for high sensitivity (at 500 MHz). It also houses a solid-state 400 MHz spectrometer fitted with a 19F-NMR MAS accessory and sample changer, which is rather uncommon to find operational under cGMP. In addition, Spinnovation runs an XRPD from Empyrean Panalytical, an ICP-OES 7100 from Agilent as well as different HPLC/UPLC-(Q) TOF systems.

All these capabilities and expertise are gathered in Eurofins’ new European Centre of Excellence for NMR and XRPD in the Netherlands.

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