Analytical Services

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. Our team understands the requirements for a robust and predictable process that supports scale-up, GMP manufacturing, and regulatory requirements.

Let us help you with your custom method development, including:

  • Qualification
  • Validation
  • BioProduct contaminant characterization/removal
  • Recombinant Protein/ mAb characterization

Our custom and standard assays include:

HOST CELL PROTEIN (HCP) TESTING

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

HPLC/UPLC

Liquid chromatography provides an array of analytical options. C3 offers testing for protein concentration, % monomer and custom method development

 

 

A280

Final product concentration is easily determined by C3 staff without the need for custom method development

ELISA

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

SDS/IEF/ WESTERN GELS

Protein electrophoresis and western blotting offers information about protein purity, charge, and specificity while utilizing standard methodology