EMD Millipore, the life science division of Merck KGaA of Darmstadt, Germany, today announces the expansion of its upstream services into North America as part of its Provantage® Biodevelopment and Clinical Supply offering. The company's Massachusetts facilities will now offer upstream capabilities including media and feed screening, small-scale material production, and optimization of conditions for scale-up and technology transfer. This expansion allows EMD Millipore's North American customers to access the same services European customers have long received at the company's GMP biodevelopment center in Martillac, France.
Provantage® upstream services enable customers to improve yield and productivity, and reduce costs while ensuring consistent critical quality attributes. The Provantage® team leverages years of experience in media and feed screening, defining parameters and assessing robustness to optimize conditions for specific cell lines, leading to enhanced upstream manufacturing processes.
Provantage® services offer a great deal of flexibility for customers. Upon completion of upstream services, customers can elect to have the Provantage® team provide GMP drug substances. Alternatively, for customers who wish to transfer production, a global network of engineers and scientists can seamlessly transfer the new process and associated equipment to any facility, providing expert training and support to ensure a smooth and successful transition.
"Some of the largest gains in process productivity, consistency, scalability and efficiency can be achieved during the clone to media and feed steps," described Oliver Klaeffling, Head of Integrated Pharm Solutions. "It is essential to identify the optimal upstream process at an early stage as once in the clinic, these parameters often prove difficult to alter from a regulatory and economic standpoint. Our team works with clients to review their upstream strategies and identify opportunities for improvement while maintaining the desired quality characteristics."