CMC: from a back-office function to strategic priority for sterile drug products.

The article highlights how CMC has become a strategic priority in biotech, especially for sterile drug products. It explains the risks of poor CMC planning and shows how ten23 health enables regulatory, manufacturing, and investor confidence.

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Creixell Espilla-Gilart

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Introduction: CMC as a Strategic Priority

In the evolving world of biotechnology and pharmaceutical development, Chemistry, Manufacturing, and Control (CMC) has shifted from a back-office function to a front-and-center strategic differentiator. No longer just a regulatory requirement, CMC is now a critical component influencing investor confidence, partnership opportunities, and ultimately, patient outcomes. Especially in the context of sterile drug products, CMC excellence can make or break a development program, and biotech company.

According to Outsourced Pharma, the rising complexity of drug modalities—including biologics, gene therapies, and cell-based treatments—has significantly increased the stakes for CMC planning and execution. Inadequate CMC strategies can result in clinical holds, regulatory delays, and missed market opportunities. For biotech startups and growing pharmaceutical companies, that can mean lost investor interest or a diminished asset valuation or even, bankruptcy.

The Unique Demands of Sterile Drug Product Development

Sterile products present some of the most demanding requirements in pharmaceutical development. Ensuring sterility, maintaining product stability, and adhering to stringent regulatory guidelines are just the starting points. These products require meticulous design and validation of manufacturing processes, as well as precise control over contamination risks, particulate matter, and endotoxins.

Moreover, sterile drug products often involve complex formulations such as highly viscous liquid solutions, lyophilized powders, suspensions, with challenging active modalities such as biologics that are sensitive to temperature, light, and interfacial stresses. These factors all heighten the need for a robust CMC strategy foundation. The path from early development to commercial scale is laden with potential pitfalls if the right expertise and infrastructure are not in place.

The Expanding Role of CMC in Biotech Investment Decisions

Investors are increasingly scrutinizing CMC readiness as a core criterion for funding decisions. According to the article in Outsourced Pharma, approximately 40% of failed IND (Investigational New Drug) submissions are due to CMC deficiencies. Even post-approval, inadequate CMC practices can lead to supply chain disruptions, recalls, or compliance actions that tarnish a product’s reputation and viability.

When CMC is not adequately planned or implemented, several issues can emerge:

Clinical trial delays due to incomplete or non-compliant CMC sections in regulatory submissions.
Inconsistent product quality, which can undermine patient safety and therapeutic efficacy.
Manufacturing failures, such as batch contamination, poor yield, or unstable formulations.
Technology transfer issues when scaling up from lab to GMP production, causing long lead times and costly rework.
Loss of investor confidence, as the lack of a solid CMC foundation can signal higher risk and reduced asset viability.
Regulatory setbacks, including clinical holds or rejections, prolonging time to market and increasing development costs.

Well-prepared CMC data provides a clear view of a product's manufacturability, scalability, and regulatory feasibility. It reduces technical risk, supports faster clinical trial starts, and enhances deal-making with partners and investors who prioritize reliable execution.

How ten23 health Delivers CMC Excellence for the Drug Product

At ten23 health, we understand the central role that an integrated CMC strategy plays in bringing sterile drug products to life. Our team of experts supports clients from early development through commercial manufacturing with tailored, science-driven CMC services:

Strategic CMC Planning and Regulatory Support
We work closely with our partners to design and implement Development strategies that align with both regulatory expectations and commercial goals. This includes defining an adequate Target Product Profile, and Development strategy, sterile manufacturing and testing towards a comprehensive control system, and preparing high-quality CMC documentation for IND, IMPD, and BLA/MAA submissions.
Sterile Drug Product Formulation and Development
Our scientists specialize in developing formulations that are not only effective but also manufacturable and stable over time. We address key challenges such as viscosity, and container-closure (primary packaging) compatibility from the outset, addressing regulatory requirements, usability and patient safety.
Technology Transfer and Scale-Up
We facilitate seamless technology transfer between development and manufacturing sites. Our structured approach includes detailed process characterization, risk assessments, and training to ensure reproducibility at scale. Our process characterization and development utilizes representative lab experiments, and leverage our custom-designed “Line 0”, a true scale-down of the GMP aseptic filling machines operates at ten23.
Aseptic Manufacturing and Fill-Finish
ten23 health operates GMP-compliant facilities equipped for aseptic processing and fill-finish of sterile products. Whether for clinical trials or commercial market supply, we deliver precision and quality through validated processes and real-time monitoring, for example by 100% fill weight controls.
Analytical Development and Quality Control
A comprehensive control strategy needs to be adequately designed and built, based on the assessment of critical quality attributes and critical process parameters and critical material attributes related to the target product profile. Robust analytical methods are crucial to monitor critical quality attributes. We develop, validate, and apply these methods to ensure consistent product quality throughout the lifecycle.
Sustainable and Patient-Centric CMC
In line with ten23 health's commitment to People, Patients, and Planet, and being the first B-Corp Pharma CDMO, we integrate sustainability into our processes. This includes minimizing waste, optimizing resource use, and ensuring products are designed with patient usability in mind. We already operate carbon positively.

Conclusion: A Reliable CMC Partner for a Reliable Future

As the pharmaceutical industry continues to evolve, the role of Sterile Products will only grow in importance. For sterile drug product developers, selecting a partner with the right expertise, infrastructure, and vision for all, product development – sterile manufacturing – testing is critical to success.

At ten23 health, we don’t just help you meet regulatory requirements—we help you build confidence with investors, speed up timelines, and deliver safe, effective therapies to the patients who need them most.

Get in touch to learn how we can support your next sterile product development project.