EMD Millipore Expands its EMPROVE® Raw Materials Portfolio to 400 Products
30 Jan 2014
EMD Millipore, the Life Science division of Merck KGaA of Darmstadt, Germany, today announced the expansion of its EMPROVE® raw materials portfolio to 400 active pharmaceutical ingredients, excipients and biopharmaceutical materials. The products offer comprehensive application-specific documentation in addition to superior quality, allowing pharmaceutical manufacturers to reduce qualification costs and accelerate time-to-market processes.
Increase Patient Safety and Streamline Pharmaceutical Process
The portfolio includes EMPROVE® api for active pharmaceutical ingredients, EMPROVE® exp for excipients and EMPROVE® bio for biopharmaceutical materials - all of which provide the documentation needed to improve transparency and more efficiently receive necessary approvals. The ready-to-use documentation, prepared in an internationally accepted format, prevents the errors that can result from gathering the information manually, minimizing risk to patients. The pre-compiled information also helps streamline the pharmaceutical process by saving both time and money.
Depending on the application, the EMPROVE® documentation can contain information such as manufacturer and manufacturing process details, testing procedures, purity and stability data. The active pharmaceutical ingredients are manufactured according to cGMP guideline ICH Q7, the excipients are EXCiPACT™ certified and the biopharmaceutical materials can be used in both upstream and downstream process steps.
Secure Final Approvals More Efficiently
"We are proud to reach the milestone of offering 400 different EMPROVE® raw materials to our customers," said Dr. Matthias Bucerius, Head of Pharma Raw Materials. "This product line has a long-standing history of combining reliability and safety with our deep knowledge of the pharmaceutical industry's ever-changing regulatory requirements, supporting our efforts to help our customers to secure final approvals more efficiently."
For more information on the EMPROVE® product line, please click on the company website or more info links below.
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EMPROVE® api Portfolio
MerckRegistering an API is complex and thus very time-consuming. That’s why we’ve offer EMPROVE® api: high-quality raw materials for use as active pharmaceutical ingredients. EMPROVE® api raw materials are produced according to cGMP guideline ICH Q7. What’s more, all of our EMPROVE® API production plants are located in Western Europe and follow current environmental standards. And in order to support your products’ compliance with international standards, our Regulatory Affairs team offers dedicated regulatory support with access to DMFs, CEP and ASMF.EMPROVE® api Portfolio Features: Manufactured according to ICH Q7 Access provided to DMFs, CEP and ASMF CDA necessary for ASMF/DMF Regulatory documentation is charged
EMPROVE® bio Portfolio
MerckRaw material qualification is a key factor in assuring the quality and safety of biopharmaceuticals. Even still, performing tests and compiling required documentation on your own is costly and time-consuming. Enter EMPROVE® bio raw materials – your solution for getting products to market faster. EMPROVE® bio raw materials for use in biopharmaceutical production offer specifications adapted for use in upstream or downstream process steps. These dossiers contain comprehensive data on the manufacturing processes, testing procedures and purity. Select EMPROVE® bio products also comply with ACS standards.With EMPROVE® bio, you benefit from Merck Millipore’s known expertise and reputation for uncompromising reliability and safety. As a result, you can considerably accelerate your qualification, helping you to reduce your workload and costs.EMPROVE® bio Portfolio Features: Analytical Dossier- CDA necessary - Charged - In line with CTD format Basic Dossier - Available online - Free of charge Specification adapted to biopharmeceutical production process - Endotoxins: tested (partly) - Microbiology: tested (partly) - Proteases: tested (partly) - ACS reagent standard: tested (partly) - In line with CTD format
EMPROVE® exp Portfolio
MerckEMPROVE® exp for use as excipient As drug approval procedures grow stricter, regulatory requirements are becoming more demanding for excipients. Our high-quality EMPROVE® exp raw materials for use as excipients not only comply with relevant regulations, but also come with detailed documentation, facilitating lower costs of qualification, so you can get to market faster. EMPROVE® exp dossiers comprise information on the manufacturer and manufacturing process. They provide specifications in accordance with the requirements of a variety of pharmacopoeias, as well as details on impurities, stability data and a certificate of analysis (CoA). This way, we help reduce your workload and accelerate your qualification processes.EMPROVE® exp Portfolio Features: Complete Dossier (Basic, Analytical, Stability-Dossier) - Update every 12 month - CDA necessary - Charged Basic Dossier - Available online - Free of charge Analytical Dossier (Basic Dossier+Analytical Method) - CDA necessary - Charged Stability Dossier (Basic Dossier+Stability Method) - CDA necessary- Charged