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 per USP and EP monograph
Quality Control
The Analytical QC group performs product release and ICH compliant stability testing of GMP material using the qualified and / or validated methods indicated above.
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.
Testing includes:
Pharmaceutical microbiology
Endotoxin by gel clot
Bioburden and Sterility
Total Organic Carbon (TOC)
Environmental Monitoring of ISO classified rooms per ISO and USP Guidelines
High Purified water testing per USP
Product release testing per FDA/ICH/EU guidelines
Stability testing per ICH guidelines
In process control system is in place by testing all the buffers and equipment rinses with the Endotoxin/Bioburden test. Total organic carbon (TOC) is also assessed for all equipment cleaning processes to ensure that the equipment 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.
The Analytical QC group performs product release and ICH compliant stability testing of GMP material using the qualified and / or validated methods indicated above.