Title:
Developability Package 2

Description:
Developability Assessment – Package 2

Scope:

  1. Polyspecificity Assessment
  2. Integrity and Stability Assessment of the concentrated sample
    • Intact mass analysis (reduced and deglycosylated) by mass spectrometry
    • Post-translation modification by mass spectrometry
    • Aggregation analysis by SE-UPLC
    • Purity analysis by CE-SDS
    • Charge variant analysis by cIEF
    • Thermostability analysis by UNcle

3. Accelerated Stress Assessment

    • 3 cycles of Freeze/thaw followed by analytical assays below:
      Aggregation analysis by SE-UPLC
      Purity Analysis by CE-SDS

Deliverable:
Study Report including data deck

Material Required:
Antibody heavy and light chain sequences
1 mg of purified antibody
Project Initiation Fee

Timeline:
3 weeks

Price:
$14,300