Per the CRL, the FDA sought "limited" additional information on the Chemistry Manufacturing and Controls (CMC), which is part of the BLA submission. The goal of CMC is to ensure that every batch of ...
Examples of these include the use of radioactivity (for example, 33 P) or the reliance upon a secondary enzyme (such as luciferase, peroxidase or pyruvate kinase) for detection. With radioactive ...
Proliferating cells, in particular tumor cells, express a dimeric isoenzyme of pyruvate kinase, termed Tumor M2 pyruvate kinase. In the last few years, much attention has been paid to this novel ...
Proliferating cells, in particular tumor cells, are characterized by a high amount of the dimeric form of the pyruvate kinase isoenzyme type M2 (Tumor M2-PK). Tumor M2-PK can be determined in EDTA ...