Navigating Pharmaceutical Development Services: A Roadmap to Successful Biologics Drug Products

Developing biologic therapies is a complex, multi-phase journey that requires deep scientific expertise, regulatory foresight, and strategic collaboration. At Coriolis Pharma, we specialize in pharmaceutical development services that span the full spectrum of biologics drug product (DP) development—from early formulation to commercial manufacturing support. Our proven roadmap helps our clients accelerate timelines, mitigate risk, and achieve consistent product quality, all while meeting global regulatory requirements.

In this article, we explore how an integrated, phase-appropriate approach to pharmaceutical development services can enable the successful commercialization of biologics—particularly monoclonal antibodies, therapeutic proteins, antibody-drug conjugates, viral vectors, and gene and cell therapies.

Overview of Modern Pharmaceutical Development Services

Pharmaceutical development services encompass the scientific and technical activities required to translate a molecule into a stable, scalable, and patient-friendly drug product. These services typically include:

• Formulation development
• Analytical method development and validation
• Container closure system evaluation
• Process development and scale-up
• Stability and compatibility studies
• Regulatory documentation and support

Each of these activities must align with the product’s evolving Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQAs) across clinical phases I–III and through to commercialization.

A Roadmap Built on Experience and Quality by Design

Coriolis Pharma’s development philosophy is anchored in a Quality by Design (QbD) framework. We begin by defining the QTPP in collaboration with clinical, regulatory, and commercial teams to ensure that every step of development is aligned with both therapeutic goals and market requirements.

Our roadmap guides clients through each phase:

• Preclinical and Phase I: Rapid formulation development using platform and in-house approaches, generation of toxicology batches, and analytical methods that are “fit-for-purpose”. Early-phase programs benefit from our drug product development expertise, including high-throughput preformulation screening, forced degradation studies, and the use of low volume analytical tools, where available.
• Phase II and Pivotal Studies: At this stage, the focus shifts to refining the formulation for long-term stability, patient-centric delivery (e.g., pre-filled syringes), and ensuring robustness by using design of experiments (DoE) principles. Formulation development becomes more tailored, considering aggregation, viscosity, and container compatibility.
• Phase III and Commercialization: Finalization of process parameters, validation of analytical methods, and execution of stability and transport simulation studies ensure that the DP is ready for regulatory filing. Our process development and analytical development teams work closely to define control strategies and support technology transfer to commercial manufacturing sites.

Overcoming Common Challenges in Biologics Development

Biologics drug products present unique challenges due to their molecular complexity and sensitivity to environmental conditions. Our pharmaceutical development services address these challenges head-on:

• Aggregation and Particle Formation: Through rigorous formulation and analytical studies, we identify conditions that minimize degradation pathways such as aggregation, oxidation, or deamidation.
• Container-Closure Compatibility: To ensure patient safety, we assess silicone oil interactions in pre-filled syringes, and other device-related risks (like material compatibility and adsorption).
• Device Integration and Patient-Centric Design: As therapies shift toward self-administration, we support integration with autoinjectors and on-body delivery systems (OBDS) and evaluate their impact on product quality.
• Clinical In-Use Stability: Our teams conduct clinical in-use compatibility studies with IV bags, CSTDs, and infusion systems, ensuring the drug product performs safely and effectively at the point of care.

Bridging Drug Substance and Drug Product Expertise

One of the critical success factors in drug product development is the alignment between the upstream drug substance process and downstream DP requirements. Changes in host cell protein profiles, buffer compositions, or purification steps can significantly impact drug product stability and quality.

At Coriolis Pharma, we maintain a holistic view across the molecule’s lifecycle, from upstream process impacts to downstream drug product characteristics. This enables seamless integration of data and strategies across development functions, which is especially valuable when working with innovative modalities like mRNA or viral vectors.

Why choose Coriolis Pharma for Pharmaceutical Development Services?

As a science-driven CRDO partner, Coriolis Pharma is committed to helping our clients derisk and accelerate their biologics development. Here’s what sets us apart:

• Unmatched scientific expertise in biologics, biosimilars, and novel modalities
• State-of-the-art analytical and formulation capabilities
• Deep regulatory understanding
• Proven success with drug product development from early phase to commercialization

Whether you’re developing a first-in-class therapeutic or optimizing an established platform, our team is here to provide tailored support at every stage of your journey.

Ready to Start Your Drug Product Journey?

Connect with our experts to learn how Coriolis Pharma can support your biologics drug product development strategy with comprehensive pharmaceutical development services.