Flow cytometry assay validation requires different analytical approaches in preclinical and clinical settings. A fit-for-purpose (FFP) strategy allows researchers to customize the validation to ...
Validated next-generation sequencing soon will become necessary in ensuring the safety and efficacy of cell and gene ...
The last two decades have witnessed the steady growth of the protein drug market. As original recombinant products come off patent, generics/ biosimilars are also beginning to be manufactured. The ...
Published in JCO Precision Oncology, the new analytical validation standards offer an industry-wide protocol for test developersCHICAGO, Jan. 15, 2026 /PRNewswire/ -- A new consensus document ...
CHICAGO--(BUSINESS WIRE)-- Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, today announced that the validation study of ...
The authors recommend a strategy for classifying similar nonstainless-steel surfaces into three groups based upon the analytical recovery that was observed in this study. Cleaning validation and ...
Choosing the optimal time to develop a companion diagnostic alongside therapeutic products can feel like aiming at a moving target. To hit the bull’s eye, one must select the appropriate assay ...
"The human cytochrome P450 family 3 subfamily A (CYP3A) serves an important role in the metabolic transformation of approximately 50% of marketed drugs, including fentanyl, midazolam, quetiapine, ...
Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins. Impurities can have a negative impact on the stability, safety, and efficacy of protein ...
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