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Production biopharmaceutique

Merck:/topic/Upstream/beine_flare_177.jpgJump higher.
Land with confidence.

If you want your next product to fly high, it pays to use the best mammalian cell culture media you can find during upstream development. In addition to boosting volumetric productivity, this can help you to increase the traceability and consistent quality of your biopharmaceutical molecule and raise cost effectiveness. We at Merck Millipore are glad to put our resources at your service: extensive R&D expertise, comprehensive formulation know-how, leading-edge analytics, and powerful production resources – all backed by unrivalled regulatory support.

Our know-how for your success: From formulation …

Choosing Merck Millipore as your cell culture media supplier, you benefit from optimized media formulations, the finest raw materials, state-of-the-art production technologies for consistent, homogeneous deliveries, and comprehensive documentation for faster time to market. Using our global R&D resources, we design customized or proprietary cell culture media formulations that exactly fit your specific cell line requirements.

 

Our range of proprietary cell culture media includes:

… to raw material selection and production

All components for our high-quality, chemically defined cell culture media are of non-animal origin. All raw materials are either manufactured in-house, or sourced from suppliers whose standards meet our high expectations and who have undergone a strict qualification process to prove it. Many of the raw materials even fulfill our EMPROVE® qualification standard. Key requirements for qualification include certification of non-animal origin, and agreements on process changes to ensure full transparency and traceability.

To safeguard optimal quality and consistency, Merck Millipore cell culture media are produced under cGMP conditions using state-of-the-art production technology . We also constantly optimize the way we process the delicate raw materials for our media – for instance by using more gentle milling technology. And our scientifically developed packaging concept makes sure that your valuable media are protected from air, light and moisture.

Cutting-edge analytics

Our independent on-site analytics unit can assist you in optimizing your processes – or troubleshooting – in a variety of ways. For example, we develop analytical methods, support the transfer of analytic procedures (for instance, by adopting your preferred measuring method), or offer consulting on other suitable methods for individual media and applications. In addition to physico-chemical analytics and a range of microbial burden tests, we also focus on method development for media-specific issues in order to gain new product insights and to achieve high levels of reliability and security. For example, we apply NIR (near infra-red) spectroscopy for in-process control over particle size distribution and to collect forecasting information about a medium’s performance.

Comprehensive documentation for regulatory support

To simplify your registration processes, we provide a comprehensive Regulatory Information Package for each cell culture medium we manufacture. This package contains extensive documentation on the manufacture, characterization and control of the cell culture media – for example, a Certificate of Analysis, GMP Statement or TSE/BSE Certificate. The packages’ structure is in line with the CTD Module 3 format in order to support the compilation of your registration dossier.

 

Please register here to receive our electronic Regulatory Information Package free of charge.

For more information, please contact us.

 

© Merck KGaA, Darmstadt, Allemagne, 2014


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