We work with most cell lines used for manufacturing monoclonal antibodies and recombinant proteins, including CHO, NS/0, BHK, 293 as well as murine hybridomas, and all selection systems used with these lines. We have also worked with several different selection systems such as dhfr / methotrexate CHO, mycophenolic acid/xanthine, and G418 systems. Our experience includes attached or surface dependent as well as suspension culture types.
Assay development and characterization - Safety, identity, potency, and purity. It is essential to develop and validate analytical methods to measure levels of a drug (pharmacokinetics) in human serum, as well as to detect the presence of neutralizing antibodies typically generated by a patient's immune system against a protein-based drug during the clinical trial. Analytical method to insure safety, purity and efficacy of the drug candidates during the manufacturing process must be qualified during the drug development process before entering clinical trials.
GBI provides routine testing, development, validation of assays employing techniques such as:
Measurement of the ratio of protein to a chelating agent (for bioconjugation processes)
Identification of raw materials
Pharmaceutical microbiology
Endotoxin by gel clot
Bioburden, sterility, BNF
Total organic carbon (TOC)
Samples for environmental and purified water
Product release and stability testing following ICH guidelines
An integral element of aseptic processing is the ability to monitor facilities and processes for microbial organisms. GBI has established procedures for evaluation of all GMP areas and processes to ensure continuous control. Sterility testing on all final vialed products is outsourced to a qualified independent safety testing lab to provide to our clients additional and objective assurance that their products have been manufactured and are safe in accordance with USP and CFR testing requirements. Bacteristasis and Fungistasis is determined the first time a product is analyzed to ensure valid measurement of sterility testing parameters.
Endotoxin is monitored for all buffers and equipment rinses and at defined stages for in- process and final product manufacturing. Total organic carbon (TOC) is also assessed for all water system points of use and equipment cleaning processes to ensure that the equipment and materials used are clean and free of all residues from previous products.
Assay development and characterization - Safety, identity, potency, and purity. It is essential to develop and validate analytical methods to measure levels of a drug (pharmacokinetics) in human serum, as well as to detect the presence of neutralizing antibodies typically generated by a patient's immune system against a protein-based drug during the clinical trial. Analytical method to insure safety, purity and efficacy of the drug candidates during the manufacturing process must be qualified during the drug development process before entering clinical trials.