areta offers different types of analysis on biological drug substances, in-process samples and drug products:

• safety tests (sterility, endotoxins, mycoplasma, host cell proteins, host cell DNA)
• microbiological tests (total viable aerobic count, detection of specific micro-organisms, challenge tests, microbial identification)
• identity (isoeletrofocusing, Western blot, SDS-PAGE, HPLC)
• concentration, activity and immunological reactivity
• specificity
• specific contaminants and impurities (Protein A, BSA, free biotin)
• cell tests (viability, cytotoxicity), chemical analysis (pH, conductivity, water content, peroxide and free acid value)

Safety

The safety tests (sterility, endotoxins, mycoplasma and host cell proteins, host cell DNA) are conducted on raw material, drug substances, in-process samples and for the final batch release.

areta has a solid experience in setting, performing and validating safety tests for different classes of products (MCB/WCB, autologous/allogeneic cells, monoclonal antibodies, recombinant proteins, DNA vaccines), biological matrices, pharmaceuticals forms (solutions, lyophilized products, cartridges).