Cell bank safety / Bacteriophage analytics
Biotechnologically produced pharmaceutical products, live biotherapeutic products, food additives or supplements need a proper characterization over their entire manufacturing process. In industrial fermentation of bacteria and molds, cell bank-based production strains are used. The quality and safety of the cell bank is the prerequisite for the safety, purity and reliability of the finished product. Thus a validated and approved cell bank is very important for a high production quality.
MicroMol offers a complete test system for analyzing your cell banks. We offer a wide range of standard analysis and in-house validated methods to investigate at the level of the master cell bank, the working cell bank and the post-production cells. A regular monitoring at all levels also minimizes the risk of contaminations and confirms the identity and genetic stability of the cell line.
- Testing of parameters acc. to Ph.Eu.
- Identity testing
- Testing acc. to FDA-2010-D-0500
- Testing of microbial vectors for gene therapie
- Bacteriophage testing (lytic and temperate)
- Bacteriophage testing for phage therapie
- Quality control of phage stocks (sterility, genome sequencing, proteomic analysis, cytotoxicity, pyrogenicity, transmission electron microscopy, RFLP genotyping & RAPD analysis, host range determination, storage stability)
- Phage typing of bacterial strains
- Advisory services for the control of bacteriophage contaminations
- Phage monitoring in fermentation facilities
- Viral clearance studies on bacteriophage models
- Isolation of novel bateriophages
- Research and development