A Guide To Optimize Analytical Strategies Throughout The Biologics Development Life Cycle

By Roberta Bucci, Catalent Biologics

A miscalculated analytical approach can be costly to develop, perform, and maintain. Many organizations lack the in-house equipment, knowledge, and/or experience to create optimal testing methods and protocols. Catalent Biologics simplifies this process by leveraging its extensive resources to accurately assess each client’s project needs and to develop a phase-based, product-specific biological testing approach that evolves with the project needs.

Catalent's analytical method life cycle model has three stages: (i) analytical method development, (ii) formal method validation, and (iii) ongoing method verification. This stepwise approach is rooted in an understanding of the product and project phase as well as the molecule’s structure, including its degradation mechanisms. Using that information, Catalent’s analytical team creates a strategy that mitigates risks to safety and efficacy by applying a QbD/DoE approach.

Successful analytical assay development relies on a profound understanding of method development theories and the ability to prioritize the right parameters. The resulting, well-structured product life cycle drives production efficiency and higher-quality therapeutics. Each failure in method development or execution delays the delivery of crucial products to patients.