Quality control

The quality and safety of your product is our top priority. Our equipment allows for numerous analytical methods to accompany your process.

BIBITEC is experienced in the following analytical methods for in-process controls and release analytics:

• CEDEX®, CuBiAn-XC®, RP-HPLC, SEC-HPLC, SDS-PAGE, IEF, Western-Blotting, HCP ELISA, residual CHO DNA (qPCR), UV280, Protein A/L leachables​
• Analytics for cell density and viability, media nutrients, metabolites, amino acids, vitamins, protein quantity and quality.
• Virus and stability studies

Our methods are performed under qualified GMP conditions.

Furthermore we are collaborating with partners to broaden our analytical depth for process development to:

HPAEC-PAD, capillary electrophoresis, mass spectromety (MALDI-TOF, LC-ESI-TOF), lysine clipping, peptide mapping

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By working closely with partners, we can provide you with even more information about your product and process. The following methods complement quality control:

Cell bank characterization, virus TEM, in vitro Virus, endotoxins, bioburden, mycoplasma, bioactivity