What are “3 Key Trends” shaping the CDMO industry in 2023 and beyond? Quotient Sciences’ executive director of commercial, Eleanor Row, shares her thoughts with Contract Pharma.

Integrated services
Over the last year, we have witnessed an increasing demand for fully integrated drug development services to bridge the interface between discovery and early clinical development. This demand has fueled a need for greater collaboration between service providers to better support customer programs. Traditionally, the CDMO/CRO industry has been highly siloed, with outsourcing organizations operating in isolation from each other. However, we see a significant benefit in forming collaborations with other service providers in the marketplace, such as Charles River, to support customers in getting new drugs to patients faster and leverage the vast expertise that both best-in-class companies have to offer. When customers partner with integrated outsourcing providers, it presents a unique opportunity to accelerate key development timelines and eliminate the white space and supply chain challenges traditionally seen when working with multiple vendors. Our customers see a real benefit from cross-functional teams, citing clearer visibility of critical path activities, earlier and more informed decision-making, reduced risk, and reduced timelines and costs.

Drug substance
As companies increasingly seek to address areas of unmet medical need, especially for orphan and rare diseases, the ongoing trend of highly potent and complex small-molecule drug candidates continues to rise. With so many of these new chemical entities on expedited regulatory approval pathways, there is high demand for CDMOs in the drug substance space to meet ever shorter timelines and reduce costs while affording increased consideration to environmental sustainability. These trends have spearheaded the need for innovative thinking around process design, the use of more environmentally friendly non-toxic reagents, and novel continuous manufacturing technologies. At Quotient Sciences, our customers are benefiting from our innovative FlowInova project in collaboration with the University of Nottingham, which enables us to develop continuous flow processes alongside traditional batch technologies that are highly efficient and scalable for early-phase drug substance manufacturing. This novel approach allows us to produce kilograms of material at a laboratory scale within our new state-of-the-art drug substance facility in Alnwick, UK, rather than large-scale batches, thus reducing the timelines for scale-up, the amount of waste, and the quantities of material required for downstream product development. This ensures that potential new medicines for unmet needs can accelerate through pre-clinical and early-phase clinical development by keeping drug substance supply off the critical path.

Drug product
Over the last 12 months, we have seen an increase in the requirement for sterile parenteral drug manufacturing. This rise in demand has been partly fueled by an increase in the approval of oncology drugs and other prevalent therapies, but it is also due to a paradigm shift in clinical trial design, with more companies opting to include an early intravenous dose as part of their first-in-human studies. The development of parenteral drug products can be more complex and challenging than oral dose formulations, and with the requirements of Annex 1 coming into effect in August 2023, there is a greater global focus around regulatory requirements, commitment to quality, and robust processes and containment strategies for CDMOs providing these services. At Quotient Sciences’ Alnwick, UK, facility, we are making significant investments in our sterile product development capabilities to enable Annex 1 compliance while maintaining flexible aseptic manufacturing solutions to best support our customers’ programs.