Pharmaceutical Technology: Navigating the Complexities of Drug Formulation

Abzena’s Senior Manager in Analytics, Gary Watts shares his formulation development views in the latest edition of Pharmaceutical Technology. Gary’s article entitled ‘Navigating the Complexities of Drug Formulation’ covers the complexities of formulation development, which is the cornerstone of the biopharmaceutical industry which is crucial for converting molecules into effective, stable, and patient-friendly medicines.

The intricate process described above is pivotal in the biologic-derived drug development lifecycle. The process involves a delicate balance of scientific rigor and practical application. Abzena’s formulation development experts not only need a solid, well founded understanding of the drug’s properties, they must also must navigate the many challenges of delivering the drug in a viable, patient-centric manner.

This is a balancing act. Scientific complexities and practical realities, like manufacturability and regulatory hurdles are key to ensuring that drugs are not only effective, but also accessible and acceptable to patients.

“Effective drug formulation hinges on the early detection of drug instabilities, typically achieved through a series of rigorous stress tests. A step-by-step, comprehensive process enables performing of tests designed to predict and counter potential issues that can compromise a drug’s solubility and stability. This proactive approach ensures the efficacy and safety of a new drug. Strategic decision-making in drug development is informed by the outcomes of these tests, guiding developers in refining the formulation process. By identifying formulation challenges early, potential setbacks in later stages of development can be avoided, which is essential for efficient and successful drug production.”

Read the full article on Pharm Tech.