Senior Director - Analytical Development Head Takeda Cambridge, Massachusetts
Analytical development is an area of work that covers numerous aspects of vaccine development, including product characterization and definition of critical quality attributes, in-process testing, process parameter definition, lot release and stability tracking, and support of process changes during comparability. Traditionally, assay development has been performed based on assay convenience and historical knowledge on the use of assays for similar vaccines. However, more recently quality by design tools that include the planning of an analytical strategy prior to assay development has accelerated assay development and qualification.
Learn considerations to select best analytical tools depending on the analytical control strategy.
Define areas that are impacted and covered by analytical development.
Review caveats and expectations during the implementation of analytical tools.