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Service contents (for mAb):

Seivice Service content Deliverables Timeline
Basic Developability Assessment Quality attributes Test item Stressed conditions

Report:

  • Tagg
  • Conc.
  • Purity
6-8 weeks
None 40℃ Low pH 3.5
Tagg DLS - -
Conc. UV280
Purity SEC-HPLC
Purity CE-SDS-NR
Premium Developability Assessment Quality attributes Test item Stressed conditions

Report:

  • Tagg
  • Tm
  • Conc.
  • Purity
  • Charge variant profiles
6-8 weeks
None 40℃ Low pH 3.5 Freeze-thaw
Tagg DLS - - -
Tm DSC - - -
Conc. UV280
Purity SEC-HPLC
Purity CE-SDS-NR
Charge variants icIEF

Typical Instruments

  • HPLC/UHPLC System
     

  • Capillary Electrophoresis System
     

  • Imaged Capillary Electrophoresis System

Case Studies

Developability assessment help to identify the potential developability risk and help to select the CMC candidates. Candidate C was chosen and finally succeed in CMC.

Stability Analytical methods Changes from Tday0 and Tend
Candidate A Candidate B Candidate C
Free-thaw Appearance Remain the same Remain the same Remain the same
Stressful (40oC & 2 weeks) Appearance Remain the same Remain the same Remain the same
CE-SDS-NR Decrease ca.10% Remain the same Remain the same
SEC-HPLC Remain the same Remain the same Remain the same
PTM by MS ~ 10% deamidation (not CDR) ~ 10% deamidation (not CDR) ~ 5% Oxidation (not CDR)
cIEF Acidic and basic increased Main peak changed Acidic and basic increased
Bioactivity Remain the same Remain the same Remain the same
Acidic condtion (pH3.5 & 25°C & 4h) Appearance Remain the same slight suspension slight suspension
SEC-HPLC Decreased ca. 70% Decrease ca.40% Decrease ca.5%
PTM by MS ~ 10% deamidation (not CDR) ~ 20% Oxidation ( CDR) Remain the same
cIEF Remain the same Main peak changed Remain the same
Bioactivity Remain the same Decreased Remain the same