Carole Delauney warns that sterile injectable manufacturing “is not just fill-finish”—a misconception that can cost biotech companies millions and even derail entire drug development programs. She notes, “This is unfortunately not commonly recognized in the industry, but it is a very important topic.”
Carole Delauney, a sterile injectable manufacturing expert with nearly two decades of technical expertise in contract manufacturing, has worked exclusively in sterile fill-finish since 2008. Her background in sales and business development has positioned her as what she calls a “solution provider” for complex manufacturing challenges.
In a recent podcast, Carole explains why understanding sterile injectable complexity is crucial for CDMOs and biotech companies navigating a market projected to grow from $14.4 billion in 2024 to $33.7 billion by 2035 (Source: Roots Analysis). Her insights reveal critical best practices for avoiding costly mistakes and building successful manufacturing partnerships.
Complexity of Sterile Injectable Manufacturing
The sterile injectable market surge is driven by breakthrough therapies like GLP-1 receptor agonists and an expanding biologics pipeline, with over 40% of new drug approvals now requiring sterile injectable formulations. However, many companies underestimate the technical complexity involved.
Carole explains the underlying challenge, “when a small volume of liquid is stored in a vial, the liquid has relatively high contact with the glass surface. Because vials aren’t made entirely of pure silica, substances from the glass can potentially leach into the solution. Without stability data or studies on the vial choice, this can make the diluent less stable compared to the lyophilized drug product.”
This type of complexity is not limited to vials. Similar considerations extend across filling lines, primary packaging, and even medical devices—highlighting the need for careful evaluation of technical criteria when selecting manufacturing partners. Pharma and biotech companies should consider creating synergies between partners, as this could save time and avoid pitfalls that could lead to further delays.
Bridging the Gap Between Drug Development and Manufacturing
One of the biggest challenges in drug development occurs at the handoff between drug substance development and sterile fill-finish operations. Carole describes this tension as “two worlds, trying to live and work together.”
Early-stage biotech companies often treat fill-finish as a commodity—something expected to be quick, inexpensive, and easily repeated across products. But this mindset places unrealistic demands on CDMOs.
“CDMOs have developed platform approaches with standardized packaging, sterile filters, and batch sizes,” Carole explains. “Yet these platforms cannot be applied universally across every type of drug or delivery method.”
The consequences are significant. “It’s the CMO who ultimately releases the drug product for clinical trials,” Carole notes. She highlights the stance of Swiss regulators, who reject the idea of releasing a product “under quarantine”—that is, holding manufactured batches aside while waiting for missing tests or documentation. Regulators view this as a sign of “poor project management”.
The Costs of Poor CMC Planning
Chemistry, Manufacturing and Controls (CMC) planning failures represent a critical risk that’s increasingly recognized by investors and large pharmaceutical companies. Carole notes that “a third of projects fail due to a poor understanding of CMC.”
She recalls a cautionary case: a large pharma company was evaluating a project for licensing in phase three. After reviewing the data package, they realized the program hadn’t been developed to the level expected for that stage. In effect, the asset was still at a phase two level.
The pharma offered to proceed only if the biotech accepted this downgrade. That would have significantly reduced the project’s value, so the biotech refused. As a result, the project was abandoned—it required going back and repeating key phase two steps.
Carole advises that companies must anticipate the requirements for manufacturing and partnerships early on. “The better they understand the next steps, the more they can defend their projects with tangible data in front of investors,” she says.
Supply Chain Security Challenges and Solutions
Supply chain security presents both company-level and industry-wide challenges. While strategic projects like Moderna’s COVID vaccines qualified multiple partners across the supply chain, many companies operate with dangerously limited supplier bases.
Carole recounts discussing with a major biotech VP who revealed their company had “only one drug substance manufacturer and two drug product manufacturers. Supply chain security was definitely recognized as a threat.”
The COVID crisis highlighted broader supply chain vulnerabilities, with governments now prioritizing vital medications like antibiotics and anesthetics. However, bringing manufacturing closer to markets requires rebuilding entire supply chains.
“Drug substance manufacturing has been moved to lower-cost countries. If you want to bring back drug products, you also have to bring back drug substance, which means expanding or opening chemical plants,” Carole explains.
Navigating Europe’s Fragmented CDMO Market
The European CDMO market is highly fragmented. Carole quotes industry data from Fuliginous, showing over 330 CDMOs operating 540 facilities for commercial manufacturing, making partner selection complex.
Carole emphasizes the importance of early planning, i.e twelve to eighteen months in advance: “When partners have a need, they cannot select a partner immediately. It’s important to pre-evaluate potential options so you can act quickly when the need arises.”
Small biotech companies face particular challenges. They often lack the time to prepare and tend to rely on well-known CDMOs, which may not fit their specific strategies. Without careful planning, these companies risk becoming “just a number amongst other numbers,” struggling to get the attention needed for early-stage development.
Key Evaluation Criteria Beyond Pricing
While pricing is still a consideration, Carole stresses that it is not the primary factor when selecting a CDMO for sterile fill-finish. Key evaluation criteria include:
- Cultural Fit and Communication: It’s essential that the biotech and CDMO share compatible working styles and communication approaches to ensure smooth collaboration
- Regional Differences: Practices and expectations can vary significantly between countries and regions
- Project Management Approach: CDMOs should be assessed on how they handle different stages of a project. Early-stage clinical trials require speed, flexibility, and agility, while late-stage commercial programs demand rigorous, systematic process validation
- Quality and Stability: Experience in maintaining product quality over time—including early decisions on primary packaging and long-term stability—is critical to project success
Carole also cautions that pricing assumptions should be realistic: the contract should be structured so that costs do not unexpectedly double after the project begins. Evaluating projects with well-founded assumptions helps avoid surprises and ensures a smoother collaboration.
