TABLE IV

Characterization of mAb Formulations (mAb B and mAb C) Stressed by Spray Drying or Mixing

FormulationSample DescriptionParticle Count Ratio (Stressed vs. Control Sample)1% Change in Size Variants by SEC-HPLC2
HMWsLMWs
mAb BMavag mixed (bladeless impeller with inner reservoir; (200 rpm, 60 minInner reservoir579No changeNo change
Outer reservoir1No changeNo change
Spray-dried2970.8No change
Lyophilized350.6No change
Atomized1Not testedNot tested
mAb CMavag mixed (bladeless impeller with inner reservoir; (200 rpm, 60 minInner reservoir102No changeNo change
Outer reservoir7No changeNo change
Spray-dried1308No changeNo change
Lyophilized330.60.6
Atomized16Not testedNot tested

  • ↵1 Refers to change in SvP relative to t = 0 (i.e., average particle count after stress ÷ average particle count in mAb A at t = 0).

  • ↵2 Refers to the relative difference between the stressed material and the control.