CRB: Pipeline complexity changing relationship between owners and CDMOs
CRB has published its Horizons: Life Sciences report 2022, which includes insights on the biopharma sector gained from a survey of nearly 500 Life Sciences executives in the US and Europe; they weighed in on critical issues facing their organizations.
The report covers topics such as RNA technologies, cell and gene therapies, therapeutic proteins, drug product manufacturing, and Pharma 4.0.
“Our Horizons report is a thought leadership piece. It looks at the life sciences industry and what is happening in terms of trends, innovation, and disruption,” said Peter Walters, director, advanced therapies at CRB.
The fact that the publication is based on an industry survey makes it really robust, he continued. “The report is supported at the data level as regards what companies see happening in the industry and their projections for where their businesses are going.”
Contract manufacturing and development trends
In our first deep dive into the report, we look at the insights gleaned around outsourcing trends, with companies of all sizes and stripes leveraging CMOs/CDMOs at all stages of delivery, said the authors.
More than half of the survey respondents plan to rely on CMOs/CDMOs over the next three years, and CRB also observed a rise in hybrid models—that is, owners who are offering their in-house manufacturing expertise for hire.
Once a provisional resource, CDMOs are now sought after for their expertise and have become a core component of a smart business strategy for life science innovators, reads the report.
“The idea of how CMOs/CDMOs play in the industry has changed significantly over the past few years. Ten years ago, CMOs were certainly there, but they were covernig specific niche categories such as fill-finish or, in terms of production, companies might have used CMOs for a product they were contractually obliged to manufacture, deciding to outsource that.
“Nowadays, especially with the massive increase in innovation and discovery linked to different therapeutic modalities, and the need for components such as plasmids for cell therapy and gene therapy as well as the various components and delivery mechanisms like lipid nanoparticles (LNPs) required for RNA-based therapeutics - all of this very complex spread to support such pipelines - companies are leaning very much harder on CMOs or CDMOs,” Walters told BioPharma-Reporter.
Indeed, contract manufacturers have gone from being "a sort of a back of the class option to being a pillar of how the industry is able to deliver what it does," he continued.
“And we have also seen a huge rise in the number of pharma companies who identify as a hybrid organization – they produce their own products in-house but they also offer CMO or CDMO services. That business model of taking your specialization and supporting the industry at large is going to be a huge,” said the advanced therapies specialist.
CRB is a full-service facility design, engineering, construction and consulting firm for biotech, pharma, food and beverage, and science and technology.
One-stop shop
Contract manufacturers that provide a one-stop shop service can win more business, he stressed.
“Both CMOs and CDMOs have a huge opportunity to be the partnered solution for the clients they serve, really going A-Z with the entire process, being able to do filling and finishing, being able to carry out supply chain management and helping companies with development of their products. The QC aspect was also one we saw as really resounding with a lot of the industry, with clients looking to their CDMO partner to supply comprehensive testing services as well, increasingly relying on them to be a full-spectrum provider.”
Such a partnership model can really make the difference for a lot of the smaller pharma companies in just trying to get off the ground, he said. Even for established project owners, being able to manage whole sections of their pipeline or their raw material supply chain through a partner, will be game-changing.
CMOs, though, are generally lagging pharma groups and hybrid organizations in terms of where they are on the digital path:
“But we have also seen some companies that have tried to differentiate themselves through being a CMO that is fully digitalized. They realize that while there is a certain amount of CapEx required to get going in that respect, once they have those digital technologies in place, they can then manufacture and develop and provide that full spectrum service to their clients much more effectively, with a lot more data, in a way that others are not going to be able to compete with.”
Transparent communication is key
CDMOs should take note: consistent, transparent communication could be another important differentiator when competing for contracts, found the CRB team.
According to the report, where there’s friction between CDMOs and owners, in cell therapy technology transfer situations, for example, it is the owner who’s most likely to feel it—and it usually comes down to a breakdown in communication. So, there is a real opportunity for CDMOs to differentiate themselves by prioritizing a clear, transparent partnering approach, stressed the authors.
“Fortunately, half of the cell therapy manufacturers in our survey agree that the technology transfer process between CDMOs and project owners is smooth. We would have expected a much lower satisfaction score if we’d asked this question just a few years ago, but the landscape is changing; the 'D' in CDMO—a relatively recent addition—signifies, in part, a shift towards a more customer-centric partnering approach in which cell therapy innovators and third-party manufacturers co-develop processes in a climate that’s more collaborative and less adversarial.”
