5 New Questions to Ask Before Signing with a Biologics CDMO

The value biologics CDMOs provide their innovator customers has changed radically in recent years, presenting new questions that must be answered before making a service agreement decision.

The contract development and manufacturing organization (CDMO) sector, as we know it today, formed in the late 1990s as leading pharmaceutical companies prioritized streamlining operations and refocusing their resources. During this period, many prominent global players determined that managing the extensive infrastructure required to pursue, manage, and execute all aspects of the blockbuster drug lifecycle restricted profit margins and tied up capital resources.

This was exemplified by leading pharmaceutical companies that built a network of facilities, often plants dedicated to a narrowly focused set of products, with the capacity to produce the designated product(s) at the estimated peak of their product lifecycle. The approach created tremendous excess capacity. Across the industry, pharmaceutical manufacturing utilization hovered around 30-35%--by some accounts, considerably lower.

Big Pharma then began selling their plants to the burgeoning CDMO sector. Now operated by a CDMO, these facilities produced the same products in the same facilities, using the same production lines and processes, often with the same personnel. In many cases, new CDMOs had the security of long-term contracts to manufacture innovators’ products and the opportunity to sell their remaining capacity to other pharmaceutical organizations.

The early days of the CDMO industry were all about operational efficiency, capacity management, and effective innovator resource allocation while maintaining the same product quality delivered by innovators’ manufacturing teams.

Until recently, CMDOs were generally contracted to manufacture well-understood, mature products with well-established processes. Even as the biopharmaceutical sector matured and production began transitioning to biologics CDMOs, typically, well-established, high-volume products were contracted.

To select a new CDMO, critical questions had to be asked about capacity, geographic footprint, unit operation capabilities, leadership team experience, and regulatory track records. While these characteristics continue to be foundational for any successful manufacturing partnership, CDMOs’ roles and the value they deliver to their clients are evolving.

Today’s Biologics CDMOs Are Scaling Innovation

Rather than allowing multiple pharmaceutical organizations to scale production or outsource manufacturing altogether, current successful biologics CDMOs offer their clients a curation of technically advanced capabilities. Today's CDMOs are scaling innovation, not merely scaling volume, by allowing innovators to move from proof of concept to biologics process development to commercial production without expending the time and resources needed to build and staff dedicated production facilities.

The rise of novel therapeutic constructs (including cell, gene, mRNA, and antibody therapies) has required a significant investment in new manufacturing capabilities for viral vectors, cell manipulation, nucleic acids, lipid-based formulations, and numerous other technologies. Additionally, many emerging modalities come with difficult-to-predict project timelines, the need for small batch sizes, and require highly flexible production.

CDMOs are now asked to be trusted partners for mature pharmaceuticals while also contributing technologies, experience, and expertise to enable the development and manufacture of innovative therapeutic products often sponsored by emerging biologics companies.

CMDOs have become true enablers and scalers of innovation. Therefore, innovators must ask updated questions when selecting a new biologics contract development and manufacturing organization.

5 Questions for Biologics CDMO Partner Selection

Most innovator organizations have playbooks for selecting a CDMO to effectively tech transfer established biologics manufacturing processes. However, a new set of questions must be explored to assess whether a potential partner can scale the needed innovation.

1. What is the CDMO’s capabilities expansion roadmap?

Many new therapeutic constructs require intertwined capabilities and highly specialized expertise. How does the biologics CDMO under consideration plan to keep pace with the market's evolving needs? Ultimately, this question seeks to determine if the CDMO has the potential to be a long-term partner capable of helping to scale today's innovations and tomorrow’s possibilities.

2. Which phases of biologics development can the CMDO best support?

Not long ago, the question of most CDMOs' ability to manage commercial production would have been unthinkable. However, many technologies utilized for today’s novel therapeutics are unestablished, and it is reasonable that a biologics CDMO might not yet have commercial or, in some cases, even cGMP production capabilities. However, what are the CDMO’s plans to support later phases of development, and will they be able to support your asset as it advances?

3. Does the biologics CDMO have advanced therapeutic regulatory filing experience?

The regulatory pathway for advanced therapeutics is still being established in many areas. As the industry and regulators alike learn more, product characterization and product understanding demand continually increase. An effective partner will be well-positioned to help you navigate the lack of clarity in the current guidance.

4. Is the CDMO a good cultural fit?

Cultural fit is not a new question but should be considered in a new context. Innovator and biologics CDMO organizations have always needed to work well together. However, a relationship in which a well-understood product is transferred to a contract services organization differs from true innovation collaboration. As mentioned, industry-leading biologics CDMOs have curated advanced technical capabilities to develop and produce novel therapeutics. Innovator and CDMO organizations must closely integrate their efforts, so a good cultural fit is more important than ever.

5. Can the biologics CDMO’s team augment the development effort?

Innovative biologics CDMOs add to innovators' capabilities and specialized expertise, not merely increasing workload capacity. In other words, advanced CDMOs must drive innovation by providing access to technologies, biologics process development, and additional necessary expertise the innovator does not have.

Technically Advanced Services at Scale

Scorpius BioManufacturing is fully dedicated to growing with our customers and supporting their innovation journeys. We are proud to be among a new era of biologics CDMOs helping to scale biotherapeutic advancements.

The Scorpius senior management team, technical scientists, and engineers have many decades of industry experience in all market aspects. We are directing this experience and expertise to collaborate with emerging companies developing novel therapeutics—organizations that need our help. We are energized by ongoing efforts to advance our capabilities to serve the current and future needs of the market.