Analytical Services

Extensive experience.

Our analytical team offers extensive experience in transferring, developing, qualifying, and validating client assays.

Analytical Services

Our Analytical Team offers extensive experience in developing, transferring, qualifying, and validating a wide range of client assays. We tailor each of our methods to adapt to new projects at any stage by either providing a fully integrated package of services or custom analytical development to meet unique client specific requirements. Our multidisciplinary analytical experts will design an agile analytical program that will adequately characterize your product to meet phase appropriate regulatory guidelines, from early-phase to commercial.  We offer innovative and cost effective analytical solutions with greater flexibility that enable complex molecules to quickly reach the market. We ensure clear definition of project deliverables, along with swift communication and feedback of information to all stakeholders.

  • Protein Sequence, PTM, Disulfide Bond and Peptide Map
  • Biophysical Characterization by HPLC/UPLC, CE, and iCE3
  • Glycan and Sialic Acid Analysis
  • SDS-PAGE Analysis
  • Extractable and Leachable testing
  • Cell Based Potency Assays
  • Offered through external partners
    • CD, FL, DSC, and DLS/MALS
    • BLI or Biacore and NMR (1D, 2D)
    • AUC, FFF
    • 2D HCP Coverage Analysis
  • Integrated Development/optimization support
  • Method transfer and phase-specific validation support
  • Reference standard characterization/qualification testing
  • Characterization/investigational testing
  • CGMP Lot Release testing
  • CGMP Stability testing (ICH, WHO, EMA)
  • CGMP In-process QC testing
  • Process Validation support
  • Process Impurity testing—Residual HCP, DNA, Protein A, etc.
  • Bio-similarity testing
  • Protein quantitation, Titer Assay and A280 quantitation
  • Impurity Clearance—HCP, DNA, Protein A, etc.
  • Charge Variant Analysis by cIEF & CE
  • Aggregate Analysis by SEC-HPLC
  • Glycan/Sialic Acid Variants
  • Process/Product Characterization Assays
  • Sequence Variants and Micro-heterogeneity
  • Impurity Characterization
  • Protein Sequence, PTM, Disulfide Bond and Peptide Map
  • Biophysical Characterization by HPLC/UPLC, CE, and iCE3
  • Glycan and Sialic Acid Analysis
  • SDS-PAGE Analysis
  • Extractable and Leachable testing
  • Cell Based Potency Assays
  • Offered through external partners
    • CD, FL, DSC, and DLS/MALS
    • BLI or Biacore and NMR (1D, 2D)
    • AUC, FFF
    • 2D HCP Coverage Analysis
  • Integrated Development/optimization support
  • Method transfer and phase-specific validation support
  • Reference standard characterization/qualification testing
  • Characterization/investigational testing
  • CGMP Lot Release testing
  • CGMP Stability testing (ICH, WHO, EMA)
  • CGMP In-process QC testing
  • Process Validation support
  • Process Impurity testing—Residual HCP, DNA, Protein A, etc.
  • Bio-similarity testing
  • Protein quantitation, Titer Assay and A280 quantitation
  • Impurity Clearance—HCP, DNA, Protein A, etc.
  • Charge Variant Analysis by cIEF & CE
  • Aggregate Analysis by SEC-HPLC
  • Glycan/Sialic Acid Variants
  • Process/Product Characterization Assays
  • Sequence Variants and Micro-heterogeneity
  • Impurity Characterization
What makes our analytical services stand out?
  • Ability to take on both small and large-scale projects with a rapid adaptation to changing or additional key project deliverables and metrics.
  • Extensive track record on CGMP quality and compliance. Committed to flexibility, collaboration and innovation.
  • Proven track record of successful analytical programs by applying the insight gained from our advanced biophysical protein characterization methodologies, towards the development of robust and scalable processes.
Analytical Instrumentation
Waters Alliance HPLCs
Waters Acquity/Arc UPLCs
Agilent 1100 HPLCs
Protein Simple iCE3
AB Sciex PA800+
Molecular Devices Plate Readers
BioTek Plate Readers
C Technologies SoloVPE
Thermo Evolution UV instruments
Thermo LTQ-Orbitrap XL Mass Spec
qPCR Thermo ABI 7500 Fast
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