Director Giuseppe Raucci - PhD

At Biogem we have experience in bioanalysis; we work in compliance with regulatory guidelines and our internal procedures are designed on this basis. Nonetheless, we have the flexibility to meet customer-specific analytical requirements procedures. Where needed, our methods are validated to meet EMA and/or ICH guidelines.

Also, following the inspection of the Italian Ministry of Health, we are GLP certified.

As a result, we can provide complete in vitro data packages concerning the Test Items under investigation. In particular, our expertise ranges in the following areas:

• Technologies
• Cell Based Assays
• In Vitro Enzyme assays

Liquid chromatography coupled with different types of detector:

• UV/Visible/Fluorescence;
• Mass spectrometric, either single or multiple stage.
• Chromatographic separations of proteins based on their hydrophobicity (reverse phase HPLC), electric charge properties (ion exchange HPLC) or size (size exclusion HPLC);

Affinity-based separation methods:

• Affinity capture based on paramagnetic affinity media (e.g. Dynabeads™);
• Gel-based affinity chromatography.

Protein chemistry as a sample preparation strategy for structural characterization of proteins. These strategies include:

• reduction and alkylation of disulfide bonds for separation of protein chains (e.g. L and H chains of antibodies);
• derivatization strategies for either protein immobilization or for sample tagging;
• incorporation of stable isotopes for fine characterization of covalent structure (e.g. incorporation of stable isotopes; an example is incorporation of 18O into tryptic peptides for identification of the C-terminal peptide, elucidation of amino acid sequence, degradations/post-translational modifications).
• High resolution mass spectrometry. For analysis of small molecules, the main application is metabolite profiling. On the other hand, applications to biopharmaceuticals include definition/confirmation of amino acid sequence, post-translational modifications, structural degradations, oligosaccharide structure. Normally, MS is interfaced with HPLC in order to allow hyphenated analytical schemes: like LC/MS and LC/MS/MS; alternatively, nano-LC chromatography (a miniaturized chromatography based on columns with internal diameter size of 75 mm) can be used when high sensitivity or proteomics type of analysis is needed.
• Statistics and data pharmacokinetic analysis (compartmental and non-compartmental).

Classes of molecules:

• Small molecule drugs;
• Biopharmaceuticals, including monoclonal antibodies and their derivatives.
• Fields of application

Biomolecules. Application of this methodological expertise finds use in analysis of several properties of biomolecules, including the following:

• Analysis of degradations and post translational modifications;
• Aggregation studies;
• Analysis of contaminants, product- or process-related, host cell proteins;
• Analysis of covalent structure: protein sequence, glycosylation structure of glycoproteins.
• In vitro ADME: species comparisons for appropriate pre-clinical animal model selection.

In vivo Pharmacokinetics: studies are done in mouse and rat animal models. Services include:

• Analysis of biological matrices like plasma, urine, bile, CSF and tissues;
• Drug and/or metabolite(s) profiles vs administration route.
• Method transfer and optimization;
• Drug formulation support.

Bioanalysis at different development stages of a biopharmaceutical. During the development of a biopharmaceutical, this set of skills is applies at different stages:

• Characterization (ICH Q6B);
• Comparability (ICH Q5E);
• Pharmacokinetics;
• Stability.