Module 9 2021

22/03/2021

MSD platform – example

A

100000.0

Assessment of clinical samples for presence of anti-adalimumab antibodies. Screening assay (A) and confirmatory assay (B).

10000.0

1000.0

100.0

10.0

Assay principle

Blue and purple: Adalimumab-treated patient serum samples (T0, T3, T6) Green: negative controls Red: positive control

B

Sulfo-tag adalimumab

100000.0

ADA

10000.0

1000.0

100.0

biotin-adalimumab

10.0

The Organisation for Professionals in Regulatory Affairs

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ECL technology

Advantages: • Bridging format ensures high specificity

• Signal amplification and large dynamic range of detection • Increased sensitivity and drug tolerance over ELISAs (usually) • Detection of low affinity antibodies • Ability to multiplex Disadvantages: • Dedicated equipment; single vendor • Requires labelled therapeutic - labelling could mask epitopes (conjugation ratios must be optimized) • IgG4 ADA may not be detected in bridging format

The Organisation for Professionals in Regulatory Affairs

22

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