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CMC Forum January 2018: Scientific Program
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To view the final program for Method Validation, click here.

To view the final program for Prior Knowledge, click here




Phase-appropriate Method Validation Strategies: Policies and Practices to Support Clinical Development

Numerous regulatory statutes and guidance documents expect increasing levels of cGMP compliance of CMC during clinical trial phases, including the state of validation of the analytical test methods used to test clinical trial materials. But the description of method validation activities as an ‘evolving process’ is confounded by statements (even in the same guidance) that method validation data should be provided in Phase 2 and 3 IND/CTA filings. Moreover, the proposed USP <1220> chapter on Analytical Method Lifecycles does not use the term ‘method validation’ at all; instead, it defines three method assessment stage gates which do not align with the clinical phases of product development.

There is considerable information on what is required at the end of clinical trial phases for method validation studies and data packages. ICHQ2(R1) provides guidance on the type and nature of experiments to be conducted for the validation of methods to meet commercial product cGMP compliance. Recent FDA guidance documents provide substantial clarity on the complete information sets to be included in a BLA method validation package, as well as their expectations for validation of computerized analytical systems to control data integrity for cGMP compliance.

However, except in the case of methods related to product safety, the Phase 1, 2 and 3 guidance documents do not provide clear information on expectations for the phase-appropriate rigor of the validation study protocol, or the contents of validation report produced. Is there a risk-based approach that can be applied to each method at each phase, based on the nature of the product? Is there a possibility of leveraging prior knowledge of similar methods for similar products to support the early phase validation of methods?

This Forum will discuss the current FDA and Health Canada regulatory perspectives on method validation for Phase 1, 2 and 3, and the expectations for validation data to be submitted in the IND/CTA versus the BLA/MAA Module 3 for method validation. The Forum will highlight industry strategies for application of phase-specific method validation for biomolecular assays (e.g. HPLC, CE) and bioassays (e.g. ligand binding and cell based).

Prior Knowledge: Learning from our Successes and Failures to Improve Product Development and Manufacturing

Biotechnology-based therapeutic products have been on the market for almost 35 years. Through that time, the biopharmaceutical industry and regulatory authorities around the world have together brought hundreds of biological drugs to patients suffering from a variety of diseases. The development and manufacture of new products is often based on the same principles and technologies. There is now a wealth of prior knowledge that we can and should leverage to improve the efficiency of developing new products and the manufacturing of existing products. Some areas of CMC already use prior knowledge effectively such as in the validation supporting facility design, or in the design of viral clearance and inactivation studies. Although the potential is clear, and it’s time to expand upon existing efforts, how a given manufacturer maintains, interprets and applies such a large amount of information across multiple products in a regulated environment remains a challenge. This Forum will explore ways the industry can push these concepts to speed drug development and enhance manufacturing efficiency to get safe and effective products to patients as quickly as possible.  


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