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

Insight into our laboratory

We Value Your Privacy
We use cookies on our website. Some of them are essential, while others help us to improve this website and your experience.
We Value Your Privacy
We use these technologies to analyze how this website is being used.
Name Google Analytics, Google Tag Manager
Provider Google Ireland Limited, Gordon House, Barrow Street, Dublin 4, Ireland
Purpose Cookie by Google used for website analytics. Generates statistical data on how the visitor uses the website.
Privacy Policy
Cookie Name _ga, _gat, _gid
Cookie Expiry 2 years
Customer Interaction
These technologies will allow you to contact us through our website, i.e. use the chat widget.
Name LiveChat
Provider LiveChat Software S.A., ul. Zwycięska 47, 53-033 Wroclaw, Poland
Purpose Communication with clients via online chat using the API of the chat service LiveChat.
Privacy Policy
Cookie Name __lc_cid, __lc_cst
Cookie Expiry 2 years
Technologies required to enable the core functionality of this website.
Name Cookie Consent
Provider Owner of this website, Imprint
Purpose Saves the visitors preferences selected in the cookie banner.
Cookie Name ws_cookie_consent
Cookie Expiry 1 year