Drug Development & Delivery: What is Formulation Development & Why is it Important?

Authors: Rob Holgate, VP of Research and Innovation, and Nicola Watts, Principal Scientist I

Discover how early-stage formulation can make or break a drug’s journey from the lab to the patient. In our latest article, Abzena’s experts delve into the strategic importance of formulation development – a critical yet often understated phase in drug manufacturing that balances scientific rigor with practical application. Learn how thorough developability assessments and accelerated stress studies can predict potential challenges and streamline the path to creating stable, safe, and effective therapies.

Drawing on years of expertise in biopharmaceutical development, this piece unpacks:

• The essential role of formulation in enhancing a drug’s stability and manufacturability
• The innovative methodologies that drive early detection of drug instabilities
• Strategies for optimizing lead candidate selection and mitigating late-stage risks

Rob articulates that a robust formulation strategy is essential to drug development, stating:
“The formulation of a biologic drug is a complex process that involves multiple stages, each playing a crucial role in ensuring the safety, efficacy, and manufacturability of the final product. This journey begins with a thorough understanding of the drug’s physicochemical properties. Subsequent stages involve developing and refining the formulation to address any potential challenges, optimizing it for manufacturing, and conducting extensive stability testing.”

By shining a light on how to harness a proactive approach to formulation, this article provides valuable insights for anyone looking to reduce development timelines, cut costs, and ultimately bring better medicines to market faster.

Download the full article here