The presentation on developing an effective analytical control strategy for oligonucleotide projects emphasised the importance of ensuring product quality and consistency through a well-defined strategy. Elmekawy began by highlighting the lack of a specific definition for analytical control strategy in existing guidelines, suggesting that it could be derived from the broader control strategy definitions provided by ICHQ10 and ICHQ14.
He then outlined the key elements of an analytical control strategy, starting with the definition of critical quality attributes (CQAs) that ensured product safety and efficacy. Elmekawy explained the importance of developing control points, which included process control, analytical control, and release control. Each control point played a crucial role in maintaining product quality throughout the manufacturing process.
Process control involved understanding how impurities behaved during manufacturing, using tools like RAG analysis and visualisation tools to monitor and control quality attributes. Analytical control focused on testing raw materials and in-process testing to ensure quality during manufacturing, particularly for oligonucleotides. Release control involved setting drug substance specifications and validating analytical methods to ensure the final product's safety and efficacy.
The presentation also discussed the importance of having a robust change control process in place to manage the lifecycle of the analytical control strategy. They provided examples of how different types of impurities, such as chirality and residual solvents, were controlled during the manufacturing process. Elmekawy concluded by emphasising the need for a thorough understanding of the product and process, applying appropriate controls, and considering regulatory requirements to build an effective analytical control strategy.