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.
TORONTO (PRWEB) March 04, 2020
The webinar 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.
In conclusion, the presentation will include analytical method troubleshooting case studies.
Join Arugadoss Devakumar, PhD, Director, Analytical Development, Avid Bioservices, Inc. for an informative session on Thursday, March 19, 2020 at 1pm EDT. For more information or to register for this event, visit Development to Market: Early Stage Analytical Considerations for Late Stage Success.
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