R&D PHASES

GEM FORLAB as an R&D service provider is able to support companies in every phase of the pharmaceutical and biotechnological process, according to regulatory requirements.

ABLE Bioscience – GEM FORLAB s.r.l. is a GLP and GCP certified Test Facility and we help our customers to obtain all scientific data required by regulatory entities. 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 for the various research phases.

Our offer in discovery phases involves all our platforms (IMCB, MSPP and CHEM) making our offer wide and multidisciplinary:

  • In vitro target validation;
  • Signal pathway investigation;
  • Biomarker discovery and detection;
  • Protein identification and characterization.

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.

“Development is a complex process that sees the various activities necessarily linked to each other, acting synergistic, dependent and overlapping.” (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.

NON-CLINICAL

We can perform a wide range of Pharmacokinetic/ADME tests (e.g. biodistribution, cytotoxicity, CYP inhibition and induction).

Our experts can also develop and evaluate bioanalytical methods for protein and small molecule/peptide quantification in complex matrices through different types of assays (e.g. immune-enzymatic, RT-PCR, LC-MS/MS, etc.).

CLINICAL

Our laboratories are accredited for the analysis of human samples in pharmacokinetic/ADME clinical studies (e.g. anti-drug antibodies, anti-host cell antibodies, gene expression)

We also develop and validate new bioanalytical methods for quantitative analysis of molecules/peptide/proteins in human samples through various types of assays (e.g. immune-enzymatic, RT-PCR, LC-MS/MS).

GEM FORLAB can give support for the validation of IVD equipment 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 that can be employed in various phases of pharma/medical device lifecycle.

We especially focus on detection of contamination (e.g. bacteria, viruses, mycoplasma), presence of nucleic acids, nucleases and endotoxins to verify the production process.

We perform qualitative analysis of  low and high molecular weight compounds for assessment of identity, purity and homogeneity using mass spectrometry or HPLC-UV.

Our CHEM lab can produce the necessary chemical intermediates, process impurities and reference compounds in order to verify the production process.