Cell Culture Company, LLC

Analytical Services

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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.

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Let us help you with your custom method development, including:
  • Qualification
  • Validation
  • Impurity characterization/removal
  • Recombinant Protein/mAb characterization

 

Our custom and standard assays include:
A280
  • Final product concentration is easily determined by our staff without the need for custom method development.
Isotyping
  • Isotyping offers critical information about the characterization of your monoclonal antibody. Tests are species specific and confirm heavy and light chain class and subclass.
ELISA
  • Enzyme-linked immunosorbent assays (ELISAs) provide a wide range of analytical information. We offer an array of ELISAs to suit our client’s needs, from antibody concentration in cell culture to impurity levels.
SDS-PAGE Gels / IEF Gels / Western Blots 
  • Protein electrophoresis and western blotting offers information about protein purity, charge, and specificity while utilizing standard methodology.
Size Exclusion and Affinity HPLC
  • Liquid chromatography provides an array of analytical options. We offer testing for protein concentration/ titer, % monomer, aggregation, degradation or we can create a custom method for your project.
Host Cell Protein (HCP) 
  • Clearance of host cell proteins is crucial during the purification process. We offer a variety of ELISA-based assays to quantify the removal of HCPs and ensure the quality of our client’s product.
Flow Cytometry
  • Flow cytometry offers a wide-variety of options, including analysis of cell populations.
Enzymatic Assays
  • Enzymatic assays analyze differences in cellular metabolism and growth, including collagenase/gelatinase, elastase, ADP/ATP ratio and senescence.