Protein & Peptides CMC

Monoclonal Antibodies, Proteins, and Peptides

Proteins are complex molecules that consist of one or more chains of amino acids and are derived from biological processes. Peptides consist of shorter strings of amino acids typically comprising 2-50 amino acids. These large molecules differ from each other in their size, molecular structure and physiochemical properties. The differences between proteins allow for characterization through analytical techniques.

Primera’s subject matter experts and wide array of instrumentation offer many services to analyze your protein or peptide. Our team has greater than 25 years of experience characterizing proteins including method development, transfer, and validation. Release and stability testing services include critical identity, purity and potency assays.

Primera will support your project through all phases of development and commercialization. We serve many clients with various needs that require expertise in mass spectrometry, ELISA, flow cytometry and other assays for recombinant proteins and peptides.

Protein characterization includes identification and quantification of the major and minor components. Our scientists will quantify both process and product related impurities. Primera utilizes state of the art instrumentation for analysis such as High Resolution LC/MS, Flow Cytometry (FACSCAN), qPCR, Multiple types of Plate Readers, Protein Simple iCIEF, etc.

Protein Quantification

Amino Acid Analysis (AAA) – amino acid composition of a protein without using an external standard
Extinction Coefficient (A280) – protein concentration by measuring UV absorbance at A280
Protein A HPLC (PA-HPLC) – determine the concentration of an antibody
ELISA or Mass Spectrometry

Protein Modification

Deamidation (MS. cIEF)
Oxidation (MS, RP-HPLC)
Glycosylation (MS)
Phosphorylation
N- and C- terminal truncation (MS)
Acetylation
Pyroglutamate formation
Disulfide Linkage (MS)
Free Thiols (Fluorometric)
Truncations (cGE, MS)
C-terminal Lysine (IEX, cIEF + Carboxypeptidase-B)

Aggregates

Micro-flow Imaging and Light Obscuration
SEC-UV-MALLS
Capillary Gel Electrophoresis (cGE non-reduced)

Protein Primary Structure

Peptide Mapping (MS, RP-HPLC)
Intact Mass (MS)
N- Terminal Sequencing (MS)
De-Novo Sequencing

Impurities and Variants

Process and Product Related Impurities by charge (IEX, cIEF, CZE)
Process and Product Related Impurities by size (cGE non-reduced and reduce)
Protease Activity (MS)
Host Cell Proteins (ELISA and MS)
Western Blot
Residual Host DNA (qPCR)
Endotoxin (Partner Lab)

Higher Order Structure

Infrared Spectroscopy (FTIR)
Fluorescence Spectroscopy
Differential Scanning Calorimeter (DSC)
Dynamic Light Scattering (DLS)

Glycosylation

N-Linked Glycosylation
O-Linked Glycosylation
Sialic Acid Content
Monosaccharide Analysis
Glycosylation Site

Potency

ELISA
Cell-based Assays
Binding Assays

Miscellaneous

Appearance
Color
Clarity
Turbidity
pH
Osmolality
Density
Polysorbate Quantification
Extractable Volume
pI determination (cIEF, IEF)