Sterile Formulation Strategies to Shorten Timelines for First-in-Human Studies

On the long and costly path to market, early development decisions that prepare a molecule for its clinical journey are among the most critical. Creating a complex formulation from the outset can introduce challenges and bottlenecks, potentially slowing your progress in later phases. Conversely, moving too quickly without gathering sufficient data can make it difficult to expedite timelines.

Sterile injectable drugs often require unique manufacturing and packaging considerations during formulation development. Therefore, it is essential to adopt strategies that create simple yet stable formulations for your sterile injectable products. This approach helps establish a strong foundation for the entire product lifecycle.

What you’ll learn in This Whitepaper

• Aligning Formulation Development with Clinical Trial Objectives
  Learn how to tailor formulations to meet the specific goals of each clinical trial phase.
• Accelerating Speed to Market by Mitigating Risk
  Discover how parallel development activities and data reuse can streamline timelines.
• How Thermo Fisher Scientific Develops a Formulation
  Understand Thermo Fisher’s practical, risk-conscious approach to developing stable and scalable sterile formulations.
• Practical Considerations during Formulation Development
  Gain insight into critical decisions around dose, fill volume, and batch readiness to ensure efficient clinical manufacturing.
• Considerations for Sterile Dosage Forms
  Learn how packaging, presentation, and component choices impact timelines, stability, and regulatory readiness.