Cell Bank Testing
In the production of biotechnologically manufactured pharmaceutical products, the identity, purity and quality of the microbial production strains and eukaryotic production cell lines are essential for the pharmacological safety and efficacy of the product.
As a biopharmaceutical laboratory, Tentamus Pharma & Med is specialised in the sensitive area of cell bank analysis of prokaryotic (e.g. E. coli) and eukaryotic cell lines (e.g. HEK-293, CHO). We check the purity of master cell banks (MCB), working cell banks (WCB), end-of-production cells (EOPC) and of course the expression products.
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