We perform analyses and research of proteins and polypeptides in accordance with the ICH Q6B guidelines.

Research areas cover:

the protein structure:

  • C- and N-terminal sequencing with the use of LC-MS/MS technique and enzymatic digestion,
  • peptide mapping based on the enzymatic digestion and the analysis of peptides using RP-HPLC, LC/MS/MS, MALDI-TOF/TOF,
  • defining the number and location of the disulphide bridges based on the peptide maps and the mass spectra,
  • research of secondary structure with the use of FTIR and UV,
  • research of oligomerization with the use of techniques such as light scattering, SLS, DLS, MALS,

physiochemical properties:

  • defining molecular weight with the use of mass spectrometers (Applied Biosystems): 4800 Plus MALDI-TOF/TOF and 4000 QTRAP LC/MS/MS System,
  • defining isoelectric point with the use of capillary isoelectric focusing CIEF,
  • analysis the thermodynamic stability with the use of a microcalorimeter,

analysis of impurities:

  • analysis of the protein profile impurities with the use of the RP-HPLC, SEC, IEX, CE, CIEF techniques,
  • analysis of protein aggregates based on the SEC-MALS, DLS, SLS techniques,
  • identification of process-related and product-related impurities by means of methods based on the RP-HPLC, SEC, IEX, CE, CIEF techniques,
  • identification and localization of post-translational modifications such as deamidation, acetylation, formylation etc. based on the peptide maps and the MS/MS fragmentation matrices,
  • determination of DNA and host cell derived proteins,
  • analysis of residual solvents with the use of gas chromatography (GC).
Analiza białek_1

Contacts

Dorota Stadnik, Ph.D.
phone: +48 22 37 86 155
stadnikd@iba.waw.pl

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Jacek Stadnik, M.Sc.
phone: +48 22 37 86 183
stadnikj@iba.waw.pl