# On the achievable consistency of glycan distribution in biomanufacturing of therapeutic mAbs

## TL;DR

This study shows that the glycan profiles of monoclonal antibody drugs remain consistent enough across batches to not affect their safety or effectiveness.

## Contribution

The study quantifies glycan variation in therapeutic mAbs over time, showing it remains within safe and consistent ranges.

## Key findings

- Glycan relative abundance varied by up to 4% across lots of trastuzumab and adalimumab.
- ANOVA detected a ~1% drift in glycan profiles, which is unlikely to impact drug safety or efficacy.
- Modern manufacturing processes can maintain glycan consistency within achievable ranges.

## Abstract

Recombinant monoclonal antibody (mAb) therapeutics exhibit lot-to-lot glycosylation variation influenced by manufacturing processes, which remains underexplored publicly. This study analyzed five years of trastuzumab and adalimumab lots, revealing up to 4% range of variation in glycan relative abundance and significant change or drift of ~1% by ANOVA, levels unlikely to affect mAb efficacy or safety. The results suggest that modern manufacturing can maintain consistent glycan profiles within realistically achievable ranges.