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Characterization of Biologics

What is Characterization of Biologics?

What is Characterization of Biologics?

Characterization of biologics plays an important role in the development of Biopharmaceuticals, such as monoclonal antibodies, fusion proteins, antibody drug conjugates, biosimilars etc. Characterization is the analysis of biologics to understand the primary, secondary, tertiary, and other higher order structure using physicochemical, biophysical and biological methods. During biologics drug development process, physicochemical, biophysical and biological properties can have an impact on the product's performance and safety.

Why characterize Biologics?

According to ICH Q6B guidelines, biologics characterization is the essential part of the successful development of bio-pharmaceuticals. In-depth knowledge of biologics and their chemistry, structure, and biological activities facilitates smoother process design to ensure the drug to attain critical product safety, purity, and potency.


Characterization and analysis of Biologics and Biosimilars requires highly sophisticated analytical workflows with significant emphasis on GMP and regulatory compliance. Development of both originator biotherapy and biosimilar products requires thorough characterization to ensure robust and well specified biological drug. Characterization of biologics includes identity testing, analysis of post translational modifications (PTM), physical testing, size distribution, analysis, sterility testing, impurities, etc.


Comprehensive support from discovery research into commercialization

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Our capabilities


Our laboratories are well equipped with broad analytical technologies and our expertise in high end mass spectrometry (Orbitrap and QToF) analysis allows us the ability to provide High-Resolution Accurate-Mass (HRAM) data, that meets cGLP, cGMP and regulatory requirements.

Service Offerings
Analysis of Proteins
Analysis of Proteins

We provide services for protein analysis according to ICH Q6B guidance, including the analytics as shown below.


  • Structural characterization and protein confirmation

  • Physicochemical haracterization

  • Higher order structure analysis

  • Quantitation

  • Analysis of biological activity/potency assays

  • Purity analysis

  • Quantitative and qualitative measurement of impurities

Structure Analysis
Structure Analysis
Primary Structure Analysis
Higher Order Structure Analysis

We provide services for the characterization of primary structure, higher order structure and confirmation according to EMEA, FDA and ICH guidelines. These services include:


  • Post-translational modifications (PTMs)

  • Determination of disulfide bonds

  • Aggregates characterization

  • Sialic acid analysis

  • Amino acid analysis

  • Peptide mapping

  • Intact mass analysis

  • Reduced mass analysis

  • Glycan analysis


We provide services to obtain information on higher order structure i.e., secondary, tertiary and quaternary structure according to the guidance by FDA, EMEA and ICH (Q6B, Q5E). Understanding the higher order structure is key to defining critical quality attributes. Our capabilities for higher order structure analysis include:


  • Sedimentation velocity-analytical ultra centrifugation (SV-AUC)

  • Differential scanning calorimetry (DSC)

  • Size exclusion chromatography w/ multi-angle light scattering(SEC-MALS)

  • Dynamic light scattering (DLS)

  • Far and near UV-CD studies

  • Fourier transform-infrared (FT-IR) studies

  • Intrinsic fluorescence studies

  • Surface plasmon resonance (SPR) by biacore

Analysis and Characterization of Post-Translational Modifications
Analysis and Characterization of Post-Translational Modifications

Post translational modifications are very common for biologics, due to the various modifications introduced over the lifespan of biomolecules from the point of biosynthesis to the point of complete clearance from the patients. These modifications are both enzymatic and non-enzymatic, which create great challenge for thorough characterization of the biopharmaceuticals. Common enzymatic and non-enzymatic post translational modifications of biopharmaceuticals include: deamidation, oxidation, phosphorylation, glycation, etc. These modifications may affect the structure and functions of biologics.

We provide services for analysis and characterization of post translation modifications as described below:


  • Deamidation

  • N- and C-terminal modifications

  • Oxidation

  • Glycation

  • Glycosylation analysis

    • Phosphorylation

    • Sialic acid analysis

    • Aggregation

    • Other terminal modifications


    Impurities Analysis
    Impurities Analysis

    Impurity testing along with their identification, quantification and analytical control strategies are important for the purity, safety, and quality of drug substances and drug products. Impurities often present at very low or trace levels in highly complex sample matrices, and consequently, highly sensitive and specific analytical methods are required to identify and quantify them. Based on the sources of the impurities, these impurities are divided into four categories:


    • Process-related impurities

    • Product-related impurities

    • Inorganic impurities

    • Solvents




    Forced Degradation Studies
    Forced Degradation Studies

    Forced degradation or stressed studies help to identify the degradation pathways of biologics. Identification and characterization of potential degradation species will help to establish the critical quality attributes (CQAs).

    Our services for protein degradation studies include:


    • pH stress

    • Photostability (per ICH Q1B)

    • Mechanical stress studies

    • Forced oxidation studies

    • Shipment studies

    • Aggregation studies

    • Freeze-Thaw studies



    Services on Biosimilars
    Services on Biosimilars

    Biosimilar product is a biological product that is highly similar and has no clinically meaningful differences from an existing FDA-approved innovator product. A manufacturer developing biosimilar products must show that the biosimilar product is highly similar to the innovator product by extensively characterizing the structure, function and bioactivity of the reference standard, innovator product and biosimilar product. Following analyses are performed to establish similarity between Innovator, reference standard and Biosimilar.


    • Analysis of physicochemical properties

    • Analysis of structural attributes

    • Potency assays

    • Primary structural analysis

    • N- and C-terminal sequencing

    • Intact mass analysis

    • Reduced mass analysis

    • Higher order structural analysis

    • Disulfide linkage analysis

    • Studies on other post-translational modifications


    Comparability Studies
    Comparability Studies

    Comparability studies are important to ensure that process or manufacturing changes will not adversely affect the quality, safety, efficacy, etc. of the biological product. We provide services for comparability studies according to ICH Q5E guidance which include analysis of physicochemical properties, biophysical properties and potency. Our services on comparability studies include:


    • Primary amino sequencing

    • N- and C-terminal sequencing

    • Intact mass analysis

    • Reduced mass analysis

    • Higher order structural analysis

    • Disulfide linkage analysis

    • Studies on post-translational modifications

    • Biological activity


    Biological Characterization
    Biological Characterization
    • Ligand-binding assays

    • Biological functional assays

    • Potency assays

    • Cell killing assays

    • Mechanism of action (MOA) based assays





    Service Offerings
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    Contact Us
    bd_global@crystalpharmatech.com +1-609-604-8303
    U.S
    Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey 08512, USA
    Canada
    6800 Kitimat Rd, Unit 1, Mississauga, Ontario, Canada L5N 5M1
    China
    Suite B4-101, Biobay, 218 Xinghu Street, Suzhou Industrial Park, Suzhou, China, 215123
    Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey 08512, USA
    bd_global@crystalpharmatech.com +1-609-604-8303