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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 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.
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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
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