by Lawrence Lem, PhD
Volume 2, Issue 4 (July/August 2003)
With the advent of whole cell-based therapeutics has come a growing standardized quality control and quality assurance of the processes employed for developing and manufacturing cellular materials, similar to the controls over traditional drugs and biologicals. Cellular therapeutics present unique process and quality control challenges due to the innate complexities of living cells, making it important to use whole cell assays to provide detailed pictures of the status and consistency of cell preparations that will be used to treat patients. This article illustrates how a cellular assay from Guava Technologies addresses these issues…
Citation:
Lem L. Cell Counting and Viability Assessments in the Process Development of Cellular Therapeutics. BioProcess J, 2003; 2(4): 57-60.