Production downtime due to bacteriophage infestation?
Tentamus Pharma & Med Deutschland (TPMD) specializes in GMP-compliant analysis in the field of prokaryotic cell banks. In addition to the standardized detection of TAMC and TYMC according to Ph. Eur. 2.6.12, Ph. Eur. 2.6.13, Ph. Eur. 2.6.36 and Ph. Eur. 2.6.38, we are specialized in the detection and characterization of bacteriophages. Bacteriophages are a group of viruses that infect bacteria. Loss of quality in the production line, delays in the process and even the loss of entire batches with corresponding time and financial losses are the consequences of phage contamination. The presence of bacteriophage contamination is determined by a validated method using a reference bacteriophage strain and permissive cells as positive controls. In case of phage contamination, the infectious phages can be identified. Our test platform is designed for the detection of lytic and lysogenic bacteriophages and is GMP certified.