When Millipore was purchased by Merck KGaA in 2010, becoming EMD Millipore, it increased its portfolio to some 40,000 products—from drug discovery, development, and diagnostic technologies to a broad range of pharmaceutical chemical solutions (including drug delivery compounds, API and Excipients), upstream and downstream bioprocessing offerings. But with the acquisition, EMD Millipore also set out to become more of a full-service solution provider for the life sciences.
The term “full service” is used by most solution providers in our industry, but in EMD Millipore’s case it is warranted. The company, also known as Merck Millipore outside of North America, offers many and varied services across three business units—Bioscience, Lab Solutions, and Process Solutions.
And it is expanding these services, sometimes through additional partnerships. In February, for example, it announced a partnership with Charles River Laboratories for the exclusive licensing of EMD Millipore's TrueSpike technology. TrueSpike enables removal of cell debris, DNA, and non-viral proteins from virus preparations used to validate biomanufacturing process virus clearance—reducing protein content of virus preparations up to 600-fold, the company says. The two companies will work together to integrate TrueSpike into viral clearance services provided by Charles River.
The need for expanded services will only continue to increase in the life sciences, says the company’s Vice President of Services and Solutions, Christophe Couturier, with whom I spoke at a recent biopharma industry event. Manufacturers and other companies will continue to be strapped for cash and increasingly outsource anything that is not part of their core business. “In the biosimilars and biotech market, it’s difficult to raise funds,” Couturier says. “If someone can provide facilities and expertise, you can go much further with what you have.”
Couturier says EMD Millipore is emphasizing three aspects as it expands its services: flexibility, reliability, and expertise. “Anyone who can provide these is going to satisfy the market,” he says.
The growth of the company’s solutions business is across the molecule journey, but particularly in process development, Couturier says. This includes providing customers with more expertise in project management and technical subjects—“to optimize usage of our products, and to put our expertise on the table.”
It makes sense. Couturier notes that EMD Millipore has excellent project management expertise already. It has a pool of approximately 15 full-time project managers who have years of experience at every step of process development through commercial manufacturing. “We are able to support almost every step—from a complete process to a very specific step,” he says. “It’s an expertise we’ve always had but have never proactively brought to market before.”
Another such area of expertise is in materials safety. “Since the acquisition by Merck, we’ve launched a broad program to ensure full traceability of all materials,” he says. “It’s the same for extractables and leachables in consumables. To provide information to the customer on safety and traceability is what’s important. A thorough extractables and leachables evaluation is becoming a more critical component of overall patient safety because of the increased adoption and implementation of single-use components and systems.”
Surprisingly, some customers are not yet sufficiently aware of the absolute criticality of a thorough E&L evaluation, he says. “You really have to take a proactive approach to extractables and leachables. It has to be something that becomes part of defining your process. We have already seen the growth in supporting our customers in that area and expect continued growth as the adoption of single-use becomes more prevalent across all drug manufacturing unit operations."