Laboratory 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 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
Earlier inspections by FDA, EMA,
BfArM, afssaps, AGES, NMA (Romanian authority)
Numerous inspections by
innovator and generic companies