The firm’s Emprove programme comprises 400 active pharmaceutical ingredients (APIs), excipients and biopharmaceutical materials available for use by drugmakers in order to carryout risk assessment and supplier qualification demands.
EMD Millipore – known as Merck Millipore outside of North America – has expanded the documentation and regulatory information for the portfolio, and was showcasing the enhanced offering at last week’s CPhI exhibition in Madrid, Spain.
“The new Quality Management Dossier is tailored to support drug makers’ risk assessments,” Heike Michaelis, Director of Process Solutions on the Emprove programme, told in-Pharmatechnologist.com.
“It now includes information on transparency to the chain of custody and a quality self-assessment that gives our customers proactive answers to their most frequently asked questions needed for supplier evaluations.”
The dossier now includes information such as elemental impurity reports, she added, which helps drugmakers facilitate their process optimization.
And regarding EMD’s customers, Michaelis said traditionally it has been the Big Pharma companies which are the most frequent users of its raw material dossiers.
“However, smaller pharma companies also rely on the Emprove programme because of the expertise and guidance that the dossiers can provide to them.
“With the enhanced and more tailored information we expect even more interest from both, large and small companies.”
Pay-as-you-go or contract?
We asked Michaelis how a pharma firm could access this offering, to which she said there were two possible options:
“They can either be purchased individually or drug makers can subscribe to our new Emprove Suite that allows online access to all dossiers for all products.
“A fee of 20.000€ gives access to the Emprove Suite for 2 years,” she added.
Furthermore, customers can still access the dossiers even if EMD is not the supplier for a certain raw material yet, she said.
“Accessing the Emprove dossier can provide the necessary information for drug makers throughout the whole process from raw material and supplier selection and qualification throughout risk assessment and process optimization.”