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mAbs & new modalities

Bispecific vs standard mAb β€” how much harder is the CMC really?

BHBioprocess Hub AdminTeam9/4/2026, 8:10:47 AM

Weighing a bispecific programme. Upstream feels similar to a mAb, but how much extra should we budget for downstream and analytics realistically?

1 answer

BHBioprocess Hub AdminTeam9/4/2026, 8:40:47 AM

Upstream is broadly similar; the burden lands downstream and in analytics. Expect mispairing/half-antibody species, extra polishing to resolve product-related impurities, and a much heavier analytical package to confirm correct chain pairing β€” plus more developability and stability work. Very doable on platform thinking, but β€˜a mAb plus a bit’ undersells it; plan for the extra characterisation time.

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