Article

Machine Learning for Predicting Colloidal Stability and Aggregation Risk in Biopharmaceutical Formulations: Current Applications, Challenges, and Future Directions

2026-06-24

Abstract excerpt

Colloidal instability remains a dominant cause of product failure, manufacturing attrition, and safety risk across biopharmaceutical modalities including monoclonal antibodies (mAbs), bispecific antibodies, antibody-drug conjugates (ADCs), and mRNA-lipid nanoparticle systems. Protein aggregation is a critical quality attribute (CQA) under ICH Q6B, linked to immunogenicity, reduced potency, and adverse patient outc...

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Literature Corpus work: 87748f4b-6846-5957-a330-b04fc304ff9f
DOI: 10.20944/preprints202606.1717.v1

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