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:
-
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.