From Concept to Commercialization: The Drug Product Development Journey

Turning a promising compound into a safe, effective, and commercially viable medicine is a complex, highly regulated journey.

This process - known broadly as drug product development - requires scientific expertise, regulatory know-how, and the ability to scale manufacturing efficiently and safely. From early feasibility assessments to commercial production, each stage in the journey must be carefully managed to ensure the therapeutic potential of a drug is fully realized.

In this article, we explore the key phases involved in drug product development and why partnering with an experienced CDMO like Aenova can make the difference between success and delay.

Learn more about our drug product development services.

Preformulation and Feasibility

Drug product development starts with preformulation and feasibility studies which provide the scientific and strategic foundation for everything that follows. The objective of this phase is to understand the active pharmaceutical ingredient (API) in detail before starting full-scale development.

Preformulation focuses on characterizing key physicochemical properties of the API to better understand the attributes that directly influence formulation choices, manufacturing conditions, and the drug’s eventual performance in patients. It also provides an opportunity to identify risks or challenges and to allow developers to proactively design around them.

Feasibility studies build on preformulation insights to determine whether the API can be successfully developed into a commercially viable drug product. Considerations such as the scalability of manufacturing processes, forecasting bioavailability, and evaluating patient-centric factors (such as dosage form, administration route, and usability) should all be considered.

At Aenova, we support clients from the earliest stages of development with in-depth preformulation analysis and feasibility assessment. Our scientists combine deep pharmaceutical expertise with advanced analytical capabilities to uncover critical API characteristics and anticipate development challenges to help accelerate decision-making, reduce downstream costs, and lay a strong foundation for successful drug product development.

This is supported by Aenovation® - our dedicated early-stage development program designed to fast-track the development of pharmaceutical formulations by addressing the critical challenges of low bioavailability and reducing time-to-market for poorly soluble drug candidates.

Formulation Development

Once feasibility is established, drug product development moves into the formulation stage where the API is transformed into a safe, stable, and patient-ready dosage form. At Aenova, we cover one of the most comprehensive sets of pharmaceutical dosage forms in the industry. We commonly work with solids, soft gel capsules and sterile injectables, but regardless of the format, the objective remains the same: ensure consistent performance, patient adherence, and regulatory compliance.

Formulators begin by selecting appropriate excipients for best therapeutic efficacy, patient adherence, and quality and regulatory compliance. Other objectives include improving solubility, controlling release rates, protecting the API from degradation, and masking unpleasant taste. But the commercial considerations should also be considered. A well-designed formulation must be scalable, cost-effective to produce, and stable over its intended shelf life. Even seemingly small formulation decisions - like the choice of coating or capsule material - can impact manufacturing efficiency, packaging, storage requirements, and market competitiveness.

Our formulation scientists work closely with clients to balance technical performance with commercial practicality. Our extensive experience across a broad range of dosage forms and therapeutic areas enables us to design tailored development strategies that help avoid delays and reduce risk as programs advance toward clinical and commercial milestones.

Process Development and Scale-Up

Once a robust formulation is in place, the focus shifts to process development and scale-up. The objective is to reproduce the intended product consistently, without compromising critical quality attributes from the formulation development.

Scaling up from milligrams to kilograms, or even tonnes, introduces new variables that must be identified and controlled to prevent deviations or batch failures. Process parameters, such as mixing times, temperatures and drying conditions, must be carefully optimized across all unit operations. Quality by Design (QbD) principles are frequently applied at this stage by systematically defining critical quality attributes (CQAs) and critical process parameters (CPPs), to build robust, reproducible processes that perform reliably across production runs and sites.

Scientists at Aenova have vast expertise in process development and scale-up. Our teams apply QbD principles to define and control critical process parameters, minimizing variability and ensuring consistent product quality. Whether you’re scaling from lab to pilot or full-scale GMP manufacturing, we use a risk-based approach to optimize every step - reducing the likelihood of batch failures and accelerating timelines.

Analytical and Regulatory Support

Throughout product development, analytical and regulatory support is essential to ensure quality, compliance, and successful progression towards regulatory milestones.

Analytical development focuses on building and validating methods to assess stability, purity, potency, and other CQAs to monitor product performance and confirm regulatory specifications are met throughout its lifecycle. At the same time, regulatory strategy must be integrated early, with clear alignment to the expectations of agencies such as the FDA, EMA, and other global authorities. This includes the preparation of detailed technical documentation, alignment with current guidelines, and proactive risk mitigation.

Aenova supports this dual track through in-house analytical development and regulatory support. Working closely with our clients, we develop tailored strategies that ensure analytical robustness and regulatory readiness, building a strong foundation for clinical success and future market approval.

Technology Transfer and Commercial Manufacturing

As the drug nears approval, the focus shifts to technology transfer and commercial manufacturing. Tech transfer is the process of moving production from the development site to a commercial facility, often involving scale increases, equipment changes, and process adaptations.

Successful tech transfer requires more than just replicating processes at scale - it demands clear documentation, cross-functional collaboration, and careful alignment between development and manufacturing teams. To mitigate these risks, rigorous process characterization, equipment mapping, and knowledge transfer protocols ensure continuity and control throughout scaleup.

Aenova supports clients through this complex transition with specialized scale-up expertise, state-of-the-art equipment, and vast experience in tech transfer. Our development teams ensure each process is tailored for compliance and efficiency, but also for integration into commercial manufacturing environments.

A Trusted Partner for the Entire Drug Product Journey

Successfully bringing a drug to market is the result of careful coordination across each stage mentioned above. From feasibility through to commercialization, any delays, missteps, or gaps in expertise can compromise a project.

The secret to success? Choosing the right partner for drug product development.

Whether you're a biotech company advancing your first molecule or a pharmaceutical leader expanding your portfolio, working in a collaborative partnership with an experienced CDMO will result in greater development efficiency, reduced risk, and a smoother path to market.

Aenova’s Drug Product Development Expertise

At Aenova, our capabilities span the full spectrum of CDMO development and manufacturing services, with proven expertise across a wide range of therapeutic areas and dosage forms. With our dedication to collaboration and client success, we ensure flexibility, quality, and speed to take products to market efficiently and reliably.

Are you ready to discover how Aenova can support your drug product development goals?

Wherever you are on the development journey, Aenova’s integrated expertise and global manufacturing capabilities can help bring your product to market - faster and with confidence.

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