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Analytical Services


Protein characterization and monitoring its integrity are essential to ensure the quality and the reproducibility of the methods executed in drug development process. ProCrysta offers analytical services for methods development and validation according to ICH guidelines and IND and NDA supporting activities.  Analytical services for assays include: drug substance characterization, purity, potency, process monitoring, impurities characterization and quantitation, stability, pharmacokinetics and pharmacodynamics, and for efficacy studies.

Identity

  • Molecular weight (LC-MS, SDS-PAGE, SEC)
  • Peptide mapping (RP-HPLC and LC-MS)
  • N- and C-terminal sequencing (LC-MS/MS and amino acid analysis)
  • PTMs identification (LC-MS and MS/MS)
  • Glycan analysis
  • Western blotting
  • Isoelectric focusing (IEF)

Purity:

  •  Purity by SDS -PAGE, IEF, HPLC (SEC, IEX, RP) and LC-MS

Potency:

  • Enzyme Activity (end point and kinetic) assay
  • Km and Kcat determinations
  • Substrate specificity
  • Cell based assay

Process monitoring assays:

  • HPLC assays: HPLC assays are developed for determination of purity, identification of impurities and degradation products, raw material selection and in process sample characterization. Different HPLC techniques used for these purposes are RP, IEX, HIC and SEC.
  • Mass Spectrometry: LC-MS, LC-MS/MS analyses for determination of molecular weight, Peptide mapping, Peptide sequencing, impurities ID, degradation products analysis, Posttranslational modifications and its sites ID and glycoprotein analysis.
  • Electrophoresis: Molecular weight (SDS-PAGE), pI determinations (IEF) and for resolution of complex protein mixtures arising from cell extracts (2D electrophoresis analysis).
  • ELISA: ELISA assays are developed for testing in vivo samples with high sensitivity detections. These assays can be utilized for antibody titer determination, efficacy study samples analysis, pharmacokinetic studies etc.

Impurities ID:

  • Characterization of process (endotoxin, IPTG etc) and product related impurities
  • Degradation products ID and its quantification (oxidation, deamidation and truncations /clippings)
  • Aggregation

Bio-assays:

  • Assays for PK/PD and efficacy studies (ELISA and HPLC)
  • ELISA for immunogenicity
  • Spectrophotometric assays/colorimetric assays for in vivo samples testing

Stability Testing for:

  • Various pHs
  • Temperatures 4°, 25° and 40°C
  • Proteases
  • Shelf life at 4°, 25° and 40°C

(Real-time and Accelerated Stability Studies)

 Monitor for oxidation, deamidation, clipping and aggregation
 

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