Development to Market: Early Stage Analytical Considerations for Late Stage Success

This webinar will provide an overview of the role analytical technology plays within the product life cycle. The goal is to showcase the wide scope of different analytical elements such as characterization, development and validation of bioanalytical methods that can be incorporated into the continuously evolving product life cycle landscape.

The speaker will highlight various parameters that are important to connect method development and QC release testing for an accurate, robust assay. Development begins with understanding the analytical target profile (ATP) and critical quality attributes (CQA) that ensure the method is ‘fit for purpose’. Scouting experiments are typically performed to evaluate method parameters to proactively build robust and rugged methods that survive the challenges of time. It is also important to define the right analytical platform for what will be measured and when it will be measured.

To successfully develop an analytical method it is critical to hit the right balance of various scientific/technical elements associated with development, validation and transfer of QC methods. Method development and validation are not discrete activities, rather, they are part of a continuously interconnected and evolving process that goes hand-in-hand with the drug product evolution. Another common challenge is that the methods are typically developed by the R&D team at one site and validated by the QC team at a different site. In such circumstances, it is important for each team to work as one team with clear communication of roles and responsibilities. To understand the stability indicating capability of an analytical method, it is important to utilize the forced degradation and accelerated stability samples to probe the strengths and subtle hidden limitations.

This webinar will also emphasize the importance of early-stage adoption of analytical product characterization to define the pattern of heterogeneity of the product using multiple orthogonal analytical approaches to demonstrate consistency of the lots used in preclinical and clinical studies. This in-depth understanding of product and process design will be a high value add to understanding the CQA that ensures the safety, purity, identity and potency profiles.

The conclusion of the presentation will include analytical method troubleshooting case studies.

Speaker

Arugadoss Devakumar, PhD, Director, Analytical Development, Avid Bioservices, Inc.

Dr. Arugadoss Devakumar received his PhD in Analytical Chemistry from Indiana University and then completed his post-doctoral fellowship at Pfizer, Inc. He is currently the director of analytical development for Avid Bioservices, Inc. located in Tustin, CA, US. Dr. Devakumar has over 15 years of experience in the pharma and biotech industry. At Avid, he and his team are responsible for analytical method development, characterization, qualification/validation, transfer and training. Prior to joining Avid, Dr. Devakumar served as an analytical team lead at various leading biotech organizations including Genentech/Roche, Thermo and Illumina focused on development and characterization of biopharmaceuticals.

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