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:
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Qualification
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Validation
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Impurity characterization/removal
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Recombinant Protein/mAb characterization
Our custom and standard assays include:
A280
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Final product concentration is easily determined by our staff without the need for custom method development.
Isotyping
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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
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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
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Protein electrophoresis and western blotting offers information about protein purity, charge, and specificity while utilizing standard methodology.
Size Exclusion and Affinity HPLC
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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)
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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
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Flow cytometry offers a wide-variety of options, including analysis of cell populations.
Enzymatic Assays
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Enzymatic assays analyze differences in cellular metabolism and growth, including collagenase/gelatinase, elastase, ADP/ATP ratio and senescence.
