Testing times: MilliporeSigma talks CDMO competition

2023 has seen multiple contract development manufacturing organizations (CDMOs) enter the Life Science space. In June, the Public Investment Fund (PIF) launched Lifera, a commercial-scale CDMO to grow Saudi Arabia’s local biopharmaceutical industry. In May, eXmoor pharma completed a $35 million Series A financing round to move the company into a full-service CGT CDMO. And one month before, recently launched CDMO VintaBio recieved  $64 million in funding to support the opening of its CGT facility in Philadelphia, US.

With so much action in what was already a competitive space, Dirk Lange, head of Life Science Services, MilliporeSigma (the life sciences division of Germany’s Merck KgaA), spoke candidly to our sister publication BioProcess Insider about setting itself apart by upping its testing services.

While some commentators in the industry deem it unnecessary to add the ‘T’ in the acronym CDMO, Lange said branding its CTDMO services has enabled the company to cover the entire value chain for its customers and acts “as a differentiator in the market.”

BI: What trends have you noticed in the CDMO space?

DL: I’ve been noticing large investments in large-scale biologics by some CDMOs, specifically by newcomers, with a concentration of growth in Asia.

It’s also become very clear that novel modalities continue to become a very significant part of the industry, with technological advances and innovations happening faster and faster. These new modalities rely even more on compressive testing and characterization capabilities, with integration being essential to accelerate the release times.

BI: Has this created different demands from the customers to the CDMOs?

DL: There is a need for differentiation happening through speed of innovation, technological leadership, and proprietary technologies to accelerate development and speed to clinic/market.

At the same time, CDMOs are moving from the transactional relationship between CMO and supplier to something that is more of a true partnership with deep collaboration to advance the client’s pipeline. Clients really value the holistic approach and these end-to-end services that include regulatory support to manage risk and complexity while reducing timelines, especially in novel modalities.

BI: Thinking of this shift in approach, what does this mean for CDMOs like MilliporeSigma?

DL: Due to the high level of CDMO competition in a space where biotech funding is being impacted by market challenges, companies are turning to whatever means necessary to differentiate themselves in this highly competitive industry. This often means ensuring a global network of services where you can meet your clients wherever they are and provide them with the capacity and capabilities to locally support their needs.

BI: What means are MilliporeSigma turning to in order to differentiate themselves?

DL: We are continuing to invest in science, technology, and innovations to be at the forefront of the industry and deliver maximum value to our clients through our end-to-end services. We offer pre-clinical, clinical, and commercial services across modalities and complete value chains. We also have drug product manufacturing services specifically for viral vectors and lipid nanoparticles.

BI: In addition to investments, is there something in particular that makes the firm different?

DL: For us, this industry environment means we needed to redefine what makes us different. We understood that our CDMO and Contract Testing Services divisions could be brought together as a differentiator in the market, branding our Millipore CTDMO services to provide a streamlined experience that covers the entire value chain for our clients from pre-clinical to commercial, with integrated testing services to help ensure the safety of the world’s therapeutics and get life-changing therapies to patients faster.

We have reframed our services to highlight our technical expertise and regulatory know-how that we provide to our clients so they can be confident in every step of their molecule’s journey. With end-to-end solutions across modalities with focused expertise, we are built to serve, advancing the model for emerging biotech’s, and partnering with companies around the world to accelerate speed to market. We’ve really thrown the old model out the window to let the breakthroughs speak for themselves, ensuring our clients are working with one trusted partner along the drug development journey.

This article was first published in BioProcess Insider on 11 October 2023