In vitro analytics
for pharmaceutical and biopharmaceutical quality control

Purity testing of bacterial cell banks (prokaryotic cell banks)

  • Identity-, purity- and quality testing of microbial cell banks, living biotherapeutic products and therapeutic bacteriophage preparations
  • Detection and identification of adventitious microbial contaminants
  • Bacteriophage presence test for monitoring and control of bacteriophage contaminations in bio production
  • Viability
  • Bacterial strain characterisation (production strains)
  • Genotyping / phenotyping (e.g. RFLP, RADP fingerprinting, phage typing, biochemical identification by API 20E, identification by 16S rDNA or ITS sequencing)
  • Plasmid copy number
  • Plasmid retention (plasmid stability)
  • Verification of consistency of the coding sequence of the expression constructs (PCR and sequencing)

Bacteriophage presence test in bacterial cell banks and fermentation samples (validated for E. coli)

  • Detection of virulent bacteriophages (lytic replication cycle)
  • Detection of temperate bacteriophages (lysogenic replication cycle)
  • Detection of prophages
  • Phage identification and bacteriophage presence tests for species other than E. coli can be developed and validated upon request

Production and safety testing of eukaryotic cell banks

  • Production of eukaryotic master and working cell banks
    • GMP-compliant expansion of the expression line
    • Production of the master and working cell bank (100 vials)
    • Cell identity testing by means of DNA fingerprinting
    • Cryopreservation in liquid nitrogen
    • GMP compliant safety testing of the expression cell line
      • Sterility, mycoplasma, cell viability, doubling rate, expression level
  • Detection of viral contamination in cell culture models MCB/WCB (Adventitious Agents in vitro Ph. Eur. 2.6.16 / 5.2.3
    • Guideline-compliant indicator cell lines: e.g. VERO 6, MRC-5, A549, HeLa, HEK-293, CHO, MDCK
    • Typical test viruses: e.g. Influenza A, HSV-1, SV40, Adenovirus
    • Testing over a period of 14 and 28 days
    • Detection of cytopathic effect (CPE), haemadsorption (HAD) and haemagglutination (HA)
    • Detection of animal pathogens (9CFR testing)
  • Adventitious agents qPCR based
    • Human respiratory syncytial virus (HRSV) of type A and type B
    • Human papilloma virus (HPV)
    • Human hepatitis virus (HAV / HBV / HCV)
    • Influenza (type A / B / C)
    • Coronavirus (SARS-CoV-2 / 229E / OC43)
    • Human Cytomegalovirus (hCMV / HHV-5)
    • Detection of other viruses upon request
  • Detection of retroviruses
    • qPCR method: product amplified reverse transcriptase (F-PERT)
    • in vitro method: S+ L- assay
  • Detection of the infectious capacity of viral vaccines
    • Testing of the production lines
    • Detection by flow cytometry
    • Determination of the TCID50
    • Determination of the expression of the genetic insert
  • Replication-Competent Virus Testing
    • Guideline compliant limits (e.g. > 1 ifu among 3 × 10E10 viral particles for Adenovirus RCA)
    • Detection: cytophatic effect, immunocytochemistry, qPCR

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