, the life-science division of Merck KGaA, reported the expansion of its Emprove raw materials portfolio to 400 APIs, excipients, and biopharmaceutical materials. The products offer detailed application-specific documentation in addition to increased quality, allowing pharmaceutical manufacturers to reduce qualification costs and accelerate time-to-market processes, according to the company.
The portfolio includes Emprove api for APIs, Emprove exp for excipients, and Emprove bio for biopharmaceutical materials, which provide the documentation to improve transparency and efficiency. The revised documentation, prepared in an internationally accepted format, prevents errors from gathering information manually and minimizes risk to patients, according to the company.
Depending on the application, the Emprove documentation can contain information regarding manufacturer and manufacturing process details, testing procedures, purity, and stability data. The APIs are manufactured according to cGMP guideline ICH Q7, the excipients are EXCiPACT certified, and the biopharmaceutical materials can be used in both upstream and downstreamprocess steps.
Source: EMD Millipore