Characterization for Biopharmaceutical Products
Characterization testing is used to gain an understanding of the physical and chemical properties of biopharmaceutical materials. During process and drug development, these properties can have an impact on the product’s performance, ability to be processed, stability and appearance. Therefore, a well characterized biopharmaceutical is integral to moving a candidate through development and to the market. Due to the complex nature of these materials, extensive testing utilizing a wide array of techniques is required.
Eurofins BioPharma Product Testing provides cGMP compliant characterization testing according to regulatory guidelines for biopharmaceutical products to support formulation or process development, biosimilar development, quality control, cGMP lot release testing, and investigational manufacturing troubleshooting.
Why Choose Eurofins BioPharma Product Testing?
- Our extensive experience with a variety of techniques and sample types lends the ability to tailor the testing to meet specific client requirements at one testing location.
- We can perform client provided methods, as well as, develop new methods when no current method exists.
- We have extensive experience with a variety of product types including:
- Therapeutic Proteins
- Monoclonal Antibodies
- Antibody-Drug Conjugates (ADCs)
- Fusion Proteins
Characterization Testing Capabilities
- Amino Acid Analysis (UPLC)
- Protein Concentration (A280, Lowry, Bradford)
- Extinction Co-efficient Determination (Beer’s Law)
- Gel Electrophoresis (SDS-PAGE, Western Blot)
- Charge Isoforms (IEF slab, strip, CE, CE-LIF, iCE)
- Bioprocess Effects – i.e. Deamidation (LTQ-Orbitrap, LC-TOF, LC-QTOF)
- Post-translational Modifications (LTQ-Orbitrap, LC-TOF, LC-QTOF)
- Aggregation (SEC and/or SEC-MALS)
- Intact (Reduced/Non-Reduced) Molecular Weight Determination (MALDI-TOF/TOF, LCTOF)
- Peptide Mapping and Sequencing (LC-TOF, LTQ-Orbitrap)
- Disulfide Mapping (LTQ-Orbitrap, LC-TOF, LC-QTOF)
- Free Thiol Analysis (Ellman’s)
- Carbohydrate Profile/Sequence (LC-TOF, CE-LIF)
- Higher Order Structure (CD)
- Enzyme Kinetics (UV, Fluorescence)
- Identification of Protein Impurities (LTQ-Orbitrap,LC-TOF, LC-QTOF)