What are “3 Key Trends” shaping the CDMO industry in 2024 and beyond? Purolite’s senior director of global marketing and strategy, Stacey Treichler, shares her thoughts with Contract Pharma.

Speed is king
For CDMOs’ customers—often smaller, pre-revenue biotechs—speed is critical. These companies are highly motivated to get to the next milestone of their project fast, be it at the early preclinical stages or already beyond phase 2 of clinical trials.

For many smaller biotechs, getting to first-in-human trials is a vital step as it enables them to start collecting patient data. Innovator companies often rely on funding raised in investment rounds, and the future of the business may depend on them showing progress—in the form of patient data—to their investors to secure further funding. This is why finding a CDMO that can help them meet aggressive timelines features highly on their agenda.

One way of compressing timelines is using a CDMO’s developed and proven platform that can take standard monoclonal antibodies (mAbs) from DNA sequencing all the way to GMP-manufactured product. For CDMOs that invest in developing these platforms, it is vital to show they are sufficiently robust to produce enough product to begin clinical trials.

Recognizing the importance of speed and the need to generate enough of the product for their customers, some CDMOs have started offering a risk-sharing model, where they guarantee a specific quantity of the product within an agreed time frame or face financial penalties. CDMOs’ significant investment in their platforms and their high motivation to achieve success for their customers mean that they survey their processes closely and look for the most efficient options. This includes purification technologies. As CDMOs increase the efficiency of their upstream process, generating higher titers, often with higher cell densities, they need to ensure that downstream purification enables high yields with low host cell protein.

Innovator companies whose future often depends on the success of their chosen molecule look for a CDMO demonstrating accountability and a true partnership that aims to get them to their next milestone as quickly and efficiently as possible.

Expertise in complex molecules
As the biotech pipeline moves from traditional mAbs toward new, sophisticated therapeutic approaches, such as bispecific antibodies (BsAbs) and fusion molecules, CDMOs are keen to showcase their expertise in these novel, specialized areas. Having the expertise and capability to develop and manufacture these innovative formats is becoming a key CDMO differentiator.

As many timesaving CDMO platforms are developed for standard mAbs, new approaches are needed for more complex modalities. This presents an opportunity for smaller, specialized CDMOs to streamline their complex molecule development timelines and deliver these new antibody variants at speed.

An important area where CDMOs can bring value to their customers is by quickly developing processes that generate high titers, leveraging solutions and consumables already tested and validated to serve the unique needs of complex molecules rather than relying on standard options. This is especially crucial for purification methods, as traditional purification approaches have proven insufficient for specialized antibody variants.

CDMOs ready to take on the challenge of solving niche issues and extending their offering to complex molecule programs can attract innovator companies looking for specialized expertise, robust and proven processes and efficient timelines to reach their next milestone.

Keeping COGS under control
CDMOs are typically responsible for sourcing all materials and consumables for their customers, from the upstream to downstream processes. Due to the variability of their customers’ needs, they are often sourcing similar products (for example cell culture media) from multiple vendors. CDMOs must carefully manage the stock of these materials so that they do not end up with unused, expired material. Forecasting and inventory planning can be challenging because CDMOs do not always have long-term visibility of their customers’ needs. Where possible, establishing strategic relationships with suppliers can allow them to receive priority access and favorable pricing, which can allow them to help their customers meet their timeline and cost-efficiency goals.

Securing all the required highest-quality materials and consumables at speed and keeping the cost of goods sold (COGS) under control is crucial to successfully developing and manufacturing the customer’s product and attracting new business.