GEM FORLAB as an R&D service provider is able supports companies all through the pharmaceutical and biotechnological processes, according to regulatory requirements.
ABLE Bioscience – GEM FORLAB s.r.l., being a GLP and GCP certified Test Facility supports customers in fullfilling all regulatory requiremnts. Even when GLP/GCP is not required, our internal Quality Management System is fully inspired by GxP principles.
“The process of discovery is to convert a subjective concept into an objective knowledge” (SILVANO FUMERO)
GEM FORLAB provides its partners with a solid base of scientific and technological knowledge. Problem solving, experience, and versatility allow us to obtain consistent results in the various research phases.
Involving all our platforms (IMCB, MSPP and CHEM) our offer is wide and multidisciplinary:
The chemistry unit provides all essential components for early drug discovery such as synthesis of chemical intermediates, process impurities, reference compounds, drug metabolites, and pro-drugs.I
“Development is a complex and multistep process consisting of various activities necessarily interconnectedin a synergistic, dependent and partly overlapping way” (SILVANO FUMERO)
At GEM FORLAB we acknowledge the importance of integrating different disciplines, approaches and professionals in the development process.
Thanks to our multidisciplined background and partnerships we can provide a broad spectrum of possibilities for non-clinical and clinical development , in compliance with regulatory requirements.
GEM FORLAB can operate both in non-Clinical and Clinical Development phases.
Services for NON-CLINICAL phase
A wide range of Pharmacokinetic/ADME tests (e.g. biodistribution, cytotoxicity, CYP inhibition and induction).
Developement and validation of bioanalytical methods for protein and small molecule/peptide quantification in complex matrices by means of different types of assays (e.g. immune-enzymatic assays, RT-PCR, LC-MS/MS, etc.).
Services for CLINICAL phase
Certified analyses of human samples in pharmacokinetic/ADME clinical studies (e.g. anti-drug antibodies, anti-host cell antibodies, gene expression)
Developement and validation of new bioanalytical methods for quantitative analysis of molecules/peptide/proteins in human samples through various types of assays (e.g. immune-enzymatic assays, RT-PCR, LC-MS/MS).
GEM FORLAB provides support for the validation of IVD equipments and reagents, including tests on different matrices and steps (extraction, amplification and result interpretation).
In addition, GEM FORLAB develops and carries out specific QC testing methods to be employed in various phases of pharma/medical device lifecycle.
Special focus on detection of contaminations (e.g. bacteria, viruses, mycoplasma), presence of nucleic acids, nucleases and endotoxins to verify the production process.
Qualitative analysis of low and high molecular weight compounds for assessment of identity, purity and homogeneity using mass spectrometry or HPLC-UV.
Production of the necessary chemical intermediates, process impurities and reference compounds in order to verify the production process.