Formulation Development Roundup
What leaders suggest are the key considerations for developing robust formulations. The post Formulation Development Roundup appeared first on GEN - Genetic Engineering and Biotechnology News .
Formulation development is a crucial step in drug production, ensuring safety, effectiveness, stability, and suitability for administration. Companies specializing in formulation development services employ best practices to achieve optimal results. GEN interviewed experts from four leading companies to understand their approaches and key risk evaluations in this process.
Abzena's Head of Formulation, Gary Watt, PhD, emphasized the importance of a developability assessment to understand how a molecule behaves under manufacturing stresses. This assessment helps identify early-risk profiles such as aggregation, fragmentation, oxidation, and deamidation, as well as any molecule-specific liabilities before starting formulation screening.
The formulation strategy should be aligned with the target product profile (TPP), including the intended dose, concentration, route of administration, and presentation requirements. Compatibility with platform analytical methods and evaluation of high-concentration feasibility are also vital considerations for subcutaneous products.
BioAgilytix's Scientific Officer, Jessica Weaver, began by understanding the molecule itself, focusing on its instability factors, quality attributes, and susceptibility to different conditions. She also highlighted the significance of excipients, as stabilizers and other formulation components can influence the drug's stability and degradation pathways.
The analytical side involves ensuring the availability of appropriate assays to detect changes in a drug's degradation pathways. The ultimate goal is to find a robust formulation that maintains performance under various conditions, not just the best performer under initial test conditions.
Curia Global's Director of Formulation R&D, Tyler Jones, Ph.D., described a bespoke approach to formulation development. This approach starts with characterizing the molecule across a wide formulation space, mapping pH and ionic strength, which are critical parameters influencing molecule presentation. Understanding the temperature-dependency of degradation pathways allows the identification of critical quality attributes and informed decision-making regarding excipients.
By systematically assessing molecule behavior and proactively mitigating issues, Curia Global can ensure the development of a robust formulation that performs consistently under various stress conditions.
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