• Soergel vor LCMS 196 x 129Laboratory space: 7500 Square feet.
     
  • Five LC-MS/MS machines: Two SCIEX API 3000, two API 5000,
    one API 5500
     
  • Ten additional LC-MS/MS machines in collaborating CRO´s during high sample load.
     
  • ELISA of therapeutic proteins like Epo,G-CSF, rGH, mAb.
     
  • Microbiology (identification, MIC, MBC, SBT, serotyping)
     
  • Modern computer facilities
     
  • On line pharmacokinetics with (micro)-dialysis techniques
     
  • Assay development of any given compound within short time, validation report within 10 days.

    We develop an LC-MS/MS or ELISA-assay in the fastest way.
    Typically four weeks between signed contract and and QA’d validation report for LC-MS/MS.
    For ELISA’s it is difficult to predict.

    We can run up to 2000 clinical samples per day on our LC-MS/MS machines.
     
  • GTF - Gesellschaft für Therapeutische Forschung

    certified by:
     

    ANVISA (2011)

    GLP (2011)

    Earlier inspections by FDA, EMA, BfArM, afssaps, AGES, NMA (Romanian authority)

     Numerous inspections by innovator and generic companies