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Biosafety of cell banks and bacterial culture systems

Biotechnologically produced pharmaceutical 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.

MicroMol offers a GMP compliant test strategy for analyzing cell banks at the master cell bank, the working cell bank and the post-production level. Regular monitoring at all stages will minimize the risk of contaminations and confirms the identity and genetic stability of the bacterial cell line.

 

Microbial cell bank characterization

 

Purity testing (tests for adventitious microbial / virus agents):

  • Detection of bacteriophage contamination (lytic and lysogenic )
  • Microbial purity according Ph. Eur. 2.6.12 and 2.6.1

Identity of the host strain (cell bank authentication)

  • Biochemical identification by API / BBL
  • Identification of E. coli as K-12 or B strain
  • DNA profiling (RAPD and RFLP analysis)
  • Identification by 16 S rDNA or ITS sequencing
  • Determination of F-genotype
  • Serology¬† and / or phage typing

Genetic stability testing

  • Plasmid stability and retention
  • Restriction map analysis
  • Sequencing of plasmids
  • Retention of selectable markers
  • Retention of recombinant constructs (plasmid retention)
  • Copy number determination

Viability testing

  • Total cell count and viable cell count
  • Residual host cell protein

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