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. 2022 Mar 17;8(4):449–460. doi: 10.1021/acscentsci.1c01479

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© 2022 The Authors. Published by American Chemical Society

Permits the broadest form of re-use including for commercial purposes, provided that author attribution and integrity are maintained (https://creativecommons.org/licenses/by/4.0/).

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Overview of process development and SF2a-TT15 bulk release. Blue panels: synthesis of GMP-grade precursor 2 (^GMP2).¹ Orange panels: maleimide activation of 4 and conjugation reaction with the introduction of 2. Green panels: process development for GMP manufacturing of SF2a-TT15 from precursor 2. Release of the (pre)-clinical conjugate vaccine DS was based on impurity assessment (NMR), free and total carbohydrate content (HPAEC-PAD), osmolality, pH, endotoxin, and aggregate content (HPSEC). HPAEC-PAD: high-performance anion-exchange chromatography with pulsed amperometric detection, HPSEC: high-performance size exclusion chromatography.