This field has evolved considerably through the integration of systematic design strategies, notably the incorporation of Analytical Quality by Design (AQbD) principles and robust statistical tools ...

Aseptic processing demands reliable, robust, and validated analytical methods to ensure sterility, safety, and quality, ...

Often, transferring an analytical method from R&D to quality control fails; success depends on determining where “the best” and “the most reliable” intersect. Analytical method transfer suffers from ...

As cell therapies become more complex, the need for robust analytical tools to characterize such products as they enter the clinic has increased in kind, especially those related to flow cytometry.

1. Research that yields conflicting results rightly causes controversy. Where methodological weaknesses are apparent, there is ready opportunity for discord within the scientific community, which may ...

Regulatory expectations and requirements continue to evolve to ensure the quality and safety of drug products. Over the last five years, we have seen increased focus during regulatory inspections ...

The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...

This course will provide you with the requisite scientific knowledge and understanding of analytical method lifecycle management, which includes the activities of validation, verification, transfer, ...

As the field of cell therapy evolves, integrating the latest technologies and robust analytical methods has never been more crucial. Join us at the 6th Cell Therapy Analytical Development Summit to ...