Charles River BPS and Protagen AG are pleased to announce a new strategic alliance to offer sophisticated protein characterization tools, including proteomics and mass spectrometry services. With this partnership, BPS can now offer services covering the entire range of protein analytics, from detailed protein characterization to stability, lot release testing and biosimilar comparability studies.
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.
|Amino Acid Composition Analysis (AAA) |
Determination of amino acid composition of a protein. Used for confirmation of primary structure.
|N- and C-terminal Sequencing |
Determination of amino acid sequence from the N- and C-terminus of protein using Edman sequencing and/or MALDI-ISD. Used as a confirmation of primary structure or de novo sequencing.
Detection of mono- and multimeric forms of protein and impurities.
|(Capillary) Isoelectric Focusing (IEF + cIEF)|
Determination of the isoelectric point (pl) of a protein and assessment of isoform distribution and impurity profiling.
Identification of proteins by their immunologic reaction with antibodies of known specificity (from 1D and 2D PAGE gels).
|SEC-HPLC-UV and SEC-HPLC-MALS|
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) and MS/MS (de novo) Protein Sequencing|
Used to confirm identity/primary structure. Enzymatic digestion of protein followed by mass spectrometry.
Quantification of neutral amino sugars: glucosamine, galactosamine, mannose, galactose and fucose.
|Carbohydrate Linkage Analysis Determination of monosaccharide linkage variants as part of a glycan structure analysis.|
|Sialic Acid Determination|
Quantitation of acidic sugars NANA (Neu5Ac) and NGNA (Neu5Gc).
N-linked and O-linked oligosaccharide profiling including analysis of sialylated and desialylated carbohydrate structures by NP-HPLC (HILIC), HPAEC-PAD and mass spectrometry.
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.
Determination of extinction coefficient and content of protein by UV and Amino Acid Analysis.
|Determination of Protein Content|
Routine determination by UV or other methods.
|Glycosylation/Sulfation/Phosphorylation Site Identification|
Mass spectrometry analysis to determine the site of post-translational modifications.
|Disulfide Bridge Analysis|
Cystine linkage sites are identified (de novo assessment and/or confirmation).
|Oxidation and Deamidation Analysis|
Mass spectrometry is used for detailed characterization of extent and site of modification.
Physicochemical testing as required for the product type (e.g., osmolality, sub-visible particulates, moisture content).
|Capillary (Zone or SDS) Electrophoresis|
Used for the characterization and separation of protein mixtures based on mass or charge.
|Batch-to-Batch Consistency/Comparability Analysis |
Used to assess the batch-to-batch variation in the manufacturing process (consistency study) or to compare batches from different sources (comparability study)
To check which of our BPS facilities offer protein characterization and analytical chemistry services, click here. For additional information, please contact us at firstname.lastname@example.org or 1.877.CRIVER.1.