Article: Right from the Start: Designing Advanceable Formulations at Phase I

The US facility is purpose-built to produce commercial-scale, non-sterile solid dose products with high scientific rigor and world-wide regulatory compliance.

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Read Serán's feature article "An evolving product development landscape for clinical development" published in the Spring 2025 issue of Pharmaceutical Manufacturing and Packing Sourcer (p.50).

As clinical timelines accelerate and drug molecules grow more complex, traditional “fail fast” strategies are proving inadequate. This site explores a modern approach to drug development that integrates early clinical flexibility, enabling formulations, and commercial readiness from day one. Learn how evolving CMC strategies are meeting the demands of precision medicine, early efficacy assessment, and scalable manufacturing to drive faster, more effective drug development.

Learn how years of proven tablet formulations and platforms demonstrated across scales and phases of clinical development can be leveraged to rapidly identify suitable and scalable formulations.

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Serán Spray Drying and Particle Engineering

Serán Dosage Form Solutions

Serán's High Concentration Protein Solutions capabilities.

In this webinar, we’ll discuss how to use this approach to strategically guide formulation technology selection. When an enabled formulation is required, we’ll discuss how these same tools can further help to guide formulation development and product design.Key takeaways:

• Successful product development and technology selection involves understanding the Active Pharmaceutical Ingredient (API) properties, having a flexible target product profile, and focusing on scalability and commercial relevance.

• Learn how to leverage the pharmaceutical classification systems and a developability assessment based on the API's molecular properties along with bio-performance modeling to predict absorption and guide program strategy.

• When an enabled formulation is required, learn how formulation and delivery technologies can be leveraged to overcome barriers associated with limited oral absorption.

Devlopment Now more than ever, accelerated product development is required to meet clinical timelines. Working with Serán to identify your lead formulation is a proven way to accelerate your development program.

Serán’s analytical labs deploy a variety of techniques to assess the physical and chemical properties of drug substances and prototype formulations. Careful collection and evaluation of the right data enables rational scientific choices leading to optimized formulations.