53Biologics can implement, develop, validate, and transfer a full quality control package including the analytical methods needed for:
Cell banking characterization following methods like Southern Blot, sequencing, qPCR, viability, analytical profile index testing, staining, bacterial & fungal impurities, etc.
Physico-chemical characterization of recombinant proteins like protein identity by SDS-PAGE (reducing and/or non-reducing conditions), Chromatographic analysis (RP, Ion exchange, etc…) of purity and identity, Residual Host Cell Proteins (HCP) and DNA, total concentrations, aggregates, endotoxin contaminations, bioburden, etc.
In-process controls (IPC) methods like optical dispersion measurement, concentrations of substrates and byproducts, mixing, dissolved oxygen, gas inlet and outlet, airflow, pressures, pH, temperatures, residual process contaminants, etc.
Just in case of biotherapeutics proteins, 53Biologics would help from the initial early-phase analysis through the more complex QC requiring methodologies for the cGMP manufacturing.
Each project should be adapted to the production host, the recombinant protein nature and/or the required specifications for application field. Considering this, each characterization strategy must be customized for each project and client.
53Biologics has proven experience characterizing a broad catalog of cell banks (bacteria like E. coli, Bacillus, etc., yeast like Pichia or Saccharomyces or fungi like Trichoderma, Aspergillus and the revolutionary C1 in addition to mammalian and insects cells.
As a result of its activity, 53Biologics has acquired a strong experience characterizing a wide range of recombinant proteins such as monoclonal, fusion, chimeric or fragment antibodies, biosimilars, enzymes as reactants or ancillary reagents, viral subunits, virus like particles, etc.
During the last years, 53Biologics has strengthen and amplified a strong network of collaborations with highly specialized analytic laboratories if more specific tests are needed for a specific product. 53Biologics has with those partner Quality and Confidentiality Agreements in place to guaranty and speed up the success of this collaborations.
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