Biopharmaceutical Testing Services | Charles River

protein & analytical chemistry 

Protein analysis is part of an integrated package of services offered by Charles River Biopharmaceutical Services (BPS) to assist clients in generating the data needed for gaining the level of product characterization required for an IND submission. Typically, these services would be used in the early stages of product development, during screening and lead candidate selection, so that the candidate taken forward into preclinical and clinical development is already well understood with relation to its primary and secondary structure.

BPS has extensive experience in developing and establishing protein characterization methods. In particular, we have established both pharmacopoeial and product-specific in vitro potency assays.

These characterization services also find a place in our stability and product release support services, where more limited packages of studies covering key identity and potency assays will be utilized.

Protein Characterization

Amino Acid Composition Analysis (AAA)
Determination of amino acid composition of a protein. Used as confirmation of primary structure.
N-terminal Sequencing
Determination of amino acid sequence from the N-terminus of protein. Used as a confirmation of primary structure.
1D/2D SDS-Page
Detection of mono- and multi-meric forms of protein and impurities.
Capillary Isoelectric Focusing (IEF)
Determination of the isoelectric point (pl) of a protein and assessment of isoform distribution and impurity profiling.
Western Blot
Identification of proteins by their immunologic reaction with antibodies of known specificity.
SEC-HPLC
Separation of protein based on size. Determination of degree of aggregation.
RP and IEX-HPLC
Identity, content and impurity determination. Detection of oxidation and deamidation products.
Peptide Mapping (by LC-MS)
Used to confirm identity/primary structure. Enzymatic digestion of protein to monitor lot-to-lot variability/post-translational modifications.
Monosaccharide Composition
Quantification of neutral amino sugars: glucosamine, galactosamine, mannose, galactose and fucose.
Salicylic Acid Determination
Quantitation of acidic sugars NANA and NGNA.
Oligosaccharide Profiling
N-linked oligosaccharide profiling by determination of the sialylated and desialylated carbohydrate structures.
ELISA/ILA
Detection and quantitation of residual proteins including BSA, Protein A and host cell proteins. Proprietary HCP assays for CHO and E. coli; also useful in bioassays and protein characterization.
UV Analysis
Determination of extinction coefficient and content of protein.
Glycosylation/Sulfation/Phosphorylation Site Identification
Using enzymes to determine the peptide location of post-translational modifications.
Disulfide Bond Pattern Determination
Determination of secondary structure. Cystine linkage sites are identified.
Mass Spectrometry of Proteins
Confirmation of protein identity by peptide mass using theoretical AA sequence. Detection of post-translational modifications.
Presentation-Specific Testing
Physico-chemical testing as required for the product type (e.g., osmolality, sub-visible particulates, moisture content).
Capillary (Zone) Electrophoresis
Used for the characterization and separation of protein mixtures based on mass or charge.
 

For more information, please contact us at askcharlesriver@crl.com or 1.877.CRIVER.1.

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For more information please call:

1.877.CRIVER.1 (1.877.274.8371)
askcharlesriver@crl.com

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