From Preclinical to Commercialization: A CRDO Approach to Accelerating Biologic Development.

The CRDO Advantage: A Smarter Approach to Drug Development

Over the past two decades, outsourcing to contract development and manufacturing organizations (CDMOs) has grown significantly. Evolving from traditional contract manufacturing organizations (CMOs), CDMOs expanded their services beyond production to include process development and other support services for both drug substance and drug products.

Recently, many large CDMOs have attempted to position themselves as “end-to-end” providers offering a full spectrum of services from early development through commercial manufacturing. While these organizations excel at scaling production efficiently, their broad approach often comes at the expense of specialized scientific expertise, like orthogonal analytical capabilities or deep formulation know-how. The drive for rapid, cost-effective solutions can sometimes lead to gaps in problem-solving, especially for companies that require in-depth characterization and optimization of their drug candidates.

A contract research and development organization (CRDO) represents a different model by building on scientific depth rather than manufacturing throughput. CRDOs specialize in drug product development and analytics, ensuring a deep understanding of molecular behavior, stability, and manufacturability. Unlike CDMOs, which must balance their R&D services with manufacturing capacity constraints, CRDOs focus exclusively on providing clients with the critical data and insights needed to advance drug candidates from preclinical studies to regulatory approval.

By collaborating with specialized partners in drug substance manufacturing, fill/finish, and packaging, CRDOs offer a more flexible, expertise-driven alternative to the traditional one-stop-shop approach. Rather than attempting to be all things to all clients, this model ensures that each stage of development is handled by the most qualified experts, reducing risks and optimizing outcomes.

Proactive Developability Assessments: Laying the Groundwork for Success

A CRDO’s focus on research and development allows for a rigorous, science-driven assessment of a drug candidate’s developability, formulatability, and manufacturability. Addressing these factors early in development is critical for identifying potential risks before they escalate into costly setbacks in later phases. In silico modeling and formulatability assessments provide valuable insights into molecular behavior, stability, and compatibility with different formulation strategies. This developability step helps streamline the transition from preclinical research to first-in-human trials.

Collaboration between a drug product-focused CRDO and a drug substance CDMO or contract research organization (CRO) further strengthens these assessments. By integrating expertise in protein folding, stability prediction, and binding activity with advanced formulation strategies, these partnerships enable more educated decision-making in clone selection, molecule design, and process development. This holistic approach ensures that candidates progress through development with the highest likelihood of success by minimizing risks and optimizing long-term manufacturability.

Coriolis Pharma: A True CRDO Partner in Drug Development

While many CROs provide a broad range of services, from analytical testing to clinical study design, few function as true CRDOs. Coriolis Pharma stands out as a specialized CRDO focused exclusively on drug product R&D. With deep-rooted expertise in formulation development and an extensive analytical method portfolio, Coriolis offers a level of scientific rigor typically found within Big Pharma’s internal development teams, remaining equally accessible to both large pharmaceutical companies and small, emerging biotechs.

For Big Pharma, Coriolis serves as an extension of in-house development groups, supplementing their capabilities with specialized knowledge and advanced analytics. For small and virtual biotechs, Coriolis acts as a critical partner, providing both the expertise and infrastructure needed to navigate early development challenges. Each client’s needs are unique, and Coriolis’ flexible approach ensures that R&D strategies are tailored to specific scientific and regulatory requirements.

Clients also benefit from Coriolis’ holistic approach, which goes beyond formulation to consider every aspect of drug product development, including manufacturing processes, fill/finish strategies, packaging materials, and administration devices. Scaled-down processing models allow for seamless technology transfers, ensuring a smooth transition from R&D to commercial-scale production.

Unlike some development partners, Coriolis does not seek to acquire client assets or secure future royalty or milestone payments. Instead, the company operates as a true collaborator, focusing on transparent communication and trust-building. Clients retain full ownership of their molecules and make final decisions regarding their selection and design, while Coriolis provides expert guidance and clear, actionable recommendations to help them avoid potential pitfalls throughout the development process. By anticipating challenges and proactively addressing risks, Coriolis enables more efficient and successful drug development pathways to help clients to bring innovative therapies to market with confidence.

Strategic Collaborations as Cornerstones in a Seamless Drug Development Ecosystem

Access to a broad and highly specialized network of experts is essential for successful drug development and commercialization. Coriolis Pharma has built its reputation not just on its in-house capabilities, but on its ability to forge strong alliances across the entire drug development life cycle. By structuring these collaborations around efficient, streamlined processes and maintaining a single point of contact for clients, Coriolis ensures that every aspect of development is expertly managed while allowing clients to experience the benefits of an integrated, one-team approach.

Key partners in this ecosystem include drug substance manufacturers, fill/finish service providers, medical device companies, packaging material suppliers, and instrument vendors, as well as large biotech and pharmaceutical companies. Each plays a critical role in advancing drug products efficiently and with minimal risk.

Seamless Integration with Drug Substance Manufacturers
Drug substance CDMOs supply the high-quality materials required for formulation screening and drug product development. Coriolis works with trusted drug substance manufacturers that bring deep expertise in cell line development, upstream and downstream processing, protein stability, and process optimization. By aligning development timelines and ensuring seamless material transfers, these collaborations enable parallel development efforts, which significantly accelerates the path to clinical readiness.

Fill/Finish Partnerships for Greater Flexibility
Coriolis’ established relationships with fill/finish providers ensure smooth transitions from drug product development to clinical and commercial manufacturing. These partners deliver GMP-compliant drug products, whether for first-in-human phase I trials or large-scale commercial distribution. Importantly, Coriolis also provides analytical testing services to support fill/finish CDMOs, either by filling certain analytical gaps or supplementing capacity. This two-way collaboration strengthens technical transfers, enhances flexibility, and creates more robust development strategies tailored to each client’s needs.

Optimizing Delivery with Medical Device and Packaging Experts
With an increasing number of biologic therapies being delivered via prefilled syringes, autoinjectors, and on-body injector devices, packaging and medical device manufacturers have become essential partners. These companies bring expertise in container closure systems, dosing accuracy, and regulatory compliance for medical devices. Because Coriolis works with a diverse range of device vendors, it can evaluate multiple options and provide clients with recommendations based on both scientific and commercial considerations. These independent collaborations ensure that drug products are delivered in the most patient-friendly and effective formats.

Driving Innovation Through Technology Collaborations
Coriolis is committed to staying at the forefront of drug product development by continuously evaluating new technologies that could enhance efficiency, quality, and scalability. A dedicated internal team actively investigates emerging innovations and works with industry-leading partners to test and integrate promising solutions. Collaborations with instrument vendors, for example, allow Coriolis to help refine cutting-edge analytical tools, ensuring that its clients always have access to the latest advancements in characterization and quality control.

By cultivating this diverse and dynamic network of collaborators, Coriolis Pharma not only strengthens its own capabilities but also provides clients with access to a best-in-class development ecosystem. These partnerships reinforce Coriolis’ position as a trusted, science-driven partner. One that enables companies to bring high-quality drug products to market faster, more efficiently, and with greater confidence.

Building Enduring Client Partnerships Through Quality and Transparency

Long-term partnerships are essential for driving successful drug development, and a CRDO’s impact is maximized when it fosters ongoing, trust-based relationships with its clients. The foundation of these relationships lies in the ability to consistently deliver high-quality services on time and in full. Achieving this requires a combination of scientific excellence, robust project management, and a proactive communication strategy.

At Coriolis Pharma, collaboration extends beyond project execution. Collaboration is embedded in how we engage with clients throughout the development process. Clearly defined roles and responsibilities across the organization ensure seamless coordination, while a strong emphasis on transparency and regular communication, internally and externally, enables fully informed decision-making. Regular cross-functional team meetings provide structured updates, while direct communication between Coriolis scientists and client teams fosters a deep level of technical engagement, allowing for real-time problem-solving and strategy adjustments.

Equally critical is Coriolis’ structured project management approach, which ensures alignment across all alliance partners and strict adherence to development timelines and quality expectations. By continuously evaluating projects against the defined quality target product profile (QTPP), Coriolis identifies potential risks early, allowing teams to implement solutions proactively rather than reactively. This consultative approach encourages clients to take a holistic view of their projects, from early developability assessments to regulatory considerations, ultimately optimizing the path to commercialization.

By prioritizing transparency, scientific rigor, and strategic foresight, Coriolis Pharma strengthens its role as a trusted partner: a partner that clients can rely on not just for individual projects, but for ongoing collaboration throughout the life cycle of their products.

Redefining the One-Stop-Shop: Expertise-Driven Collaboration

Rather than attempting to cover all aspects of drug development in-house, Coriolis Pharma has built a smarter, more effective model by uniting best-in-class expertise across the entire development and commercialization spectrum. By strategically partnering with specialized organizations in drug substance manufacturing, fill/finish, and packaging, Coriolis offers clients a seamless, integrated experience while ensuring that each stage of development is managed by the most qualified experts.

This “multi-shop” approach to creating a functional one-stop-shop brings distinct advantages over traditional CDMOs that claim to offer end-to-end services but may lack depth in certain areas. Instead of forcing clients into a rigid framework with one-size-fits-all solutions, Coriolis actively curates collaborations with partners who bring deep, highly specialized knowledge, ensuring the best possible outcomes for every project.

Coriolis’ strength lies in its core expertise in drug product development and characterization, and in advanced analytics, which has been further enhanced through significant GMP laboratory expansions in 2024 and 2025. These capabilities, combined with a robust network of alliance partners, allow Coriolis Pharma to support clients throughout the entire drug development journey, from early-stage formulation screening through commercial-scale manufacturing. By leveraging this interconnected ecosystem, Coriolis provides clients with the flexibility, scientific rigor, and strategic foresight needed to accelerate timelines while maintaining the highest quality standards.