Our highly experienced team understands that decisions made during the development of your analytical process can impact the reproducibility, scalability, and cost-effectiveness of your process. We offer a wide range of analytical services that support scale-up, GMP manufacturing, and meet regulatory requirements.
Let us help you with your custom method development, including:
- Impurity characterization/removal
- Recombinant Protein/mAb characterization
Our custom and standard assays include:
Host Cell Protein (HCP)
Clearance of host cell proteins is crucial during the purification process. C3 offers a variety of ELISA-based assays to quantify the removal of HCPs and ensure the quality of our client’s product.
Size Exclusion and Affinity HPLC
Liquid chromatography provides an array of analytical options. C3 offers testing for protein concentration/ titer, % monomer, aggregation, degradation or we can create a custom method for your project.
SDS-PAGE Gels / IEF Gels / Western Blots
Protein electrophoresis and western blotting offers information about protein purity, charge, and specificity while utilizing standard methodology.
Final product concentration is easily determined by C3 staff without the need for custom method development.
Enzyme-linked immunosorbent assays (ELISAs) provide a wide range of analytical information. C3 offers an array of ELISAs to suit our client’s needs, from antibody concentration in cell culture to impurity levels.
Isotyping offers critical information about the characterization of your monoclonal antibody. Tests are species specific and confirm heavy and light chain class and subclass.