Cell Bank Testing

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