Full Capabilities Manufacturing: Partner Reliance To Reach the Clinic Faster

Take a glimpse into the complex world of biopharma drug development and manufacturing ten years ago versus today, and it’s been a decade marked by increased pressure on biopharma companies to innovate, streamline and get therapeutics into patients’ hands faster. This has forced them to evaluate their internal capabilities and capacities and led to an increased reliance on experts outside their organizations. One of the most significant partnership shifts propelling the innovation and speed in which therapeutics are developed and ultimately delivered is the reliance by both large and small biopharma companies on contract development and manufacturing organizations (CDMOs).

There are various motivators that cause biopharma companies to seek out the expertise CDMOs provide, but a unifying result is that the partnerships allow them to focus on their core competencies while remaining agile and scalable to meet customers’ and patients’ needs.

CDMOs over the past decade have recognized this swiftly changing drug development landscape, and the most successful ones have been proactive in enhancing their own offering to benefit their customers. Previously, even the largest CDMOs might have been focused on a limited phase of the manufacturing process, such as fill-finish, or homed in on a single therapeutic modality, such as mammalian, but that narrower line of sight has shifted. Today, there is a continual and significant investment by CDMOs in R&D, staff, equipment and training that allows them to be a complete resource for customers and a true extension of their teams. An example would be a CDMO that offers an end-to-end solution, from premium cell line development to late-stage clinical manufacturing with supporting analytics. 

The partnership drivers for big and small manufacturers

What factors are increasingly driving both large and small biopharma companies to rely on a CDMO? Certainly, the challenges they face in bringing therapeutics to market, including supply chain disruptions, R&D costs, equipment and technology capital, and regulatory hurdles, are difficult to navigate. And, specifically for emerging, smaller companies, lack of expertise on strategies to streamline end-to-end processes and minimize both cost and risk plays a role. CDMOs partnering with those drug developers can guide them through program development, including timelines, the next steps to take, and how quickly and boldly they should progress.

One of the most impactful contributions CDMOs bring to their customers today (and a factor for increased engagement) is the additional expertise and innovation necessary for different drug modalities and emerging areas such as cell and gene therapy. According to a CRB Horizons Life Science 2022 study, “pipeline complexity and a push toward multimodal businesses have changed the relationship between owners and contract development and manufacturing organizations.” In fact, the study found that more than half of their survey respondents plan to rely on CDMOs over the next three years. This reliance makes sense because as advanced therapies continue to take center stage, many manufacturers won’t be able to fall back on their expertise in historical therapeutic proteins.

An additional factor that aligns with increased partnerships with CDMOs centers around the distributed manufacturing model and the resulting speed to market. By having a CDMO act as an extension of a manufacturer’s team, the manufacturer can optimize its own facility capabilities and core competencies while taking advantage of CDMO locations for other areas of production, potentially operating over an extended geographic area. This may be especially beneficial when the final product is produced near where patients are being treated.

A visionary approach to successful CDMO partnerships

History has proven that the most successful partnerships are based on taking a visionary approach to solving problems and being proactive about addressing and providing solutions for future needs. As drug substances continue to become increasingly complex, competition increases and rapid innovation is required, biopharma organizations will seek out CDMO partners to help them see ahead. They want to streamline processes and minimize the risk for their product, so it gets to market as fast as possible. This “full capabilities” CDMO partnership model allows that to happen and will continue to drive the industry in a positive direction.

About the author

A passionate executive with 17 years of operations experience, Michael Landau serves as the chief operating officer for KBI Biopharma. Michael previously served as senior VP of global operations where his focus was the management of a compliance-driven organization that can meet the complex needs of KBI’s customers. Prior to that, Michael served as VP of commercial supply in Boulder, Colorado, where he led cross-functional teams to achieve aggressive goals within the manufacturing organization. Michael has overseen large-scale equipment design and qualification, process optimization, product introduction and multi-product facility assessments. He has extensive experience in both upstream and downstream microbial production for clinical and commercial processes and has also implemented operational excellence initiatives leveraging his Six Sigma certification. He holds a Bachelor’s degree in general biology from the University of New Hampshire.