RESOURCE LIBRARY
The evidence behind every Contichrom® process. Download the open-access PPQ paper, browse application notes by molecule, watch on-demand webinars, and access the peer-reviewed publications underpinning MCSGP, CaptureSMB®, and N-Rich® at GMP commercial scale.
The first peer-reviewed PC/PPQ framework for MCSGP. 95% IPC reduction, 73% PMI reduction, 96% gross-to-gross yield — validated at GMP commercial scale on Bachem Bivalirudin.
Eisenhuth, R. & Müller-Späth, T. — Processes, 2025 (Open-Access)
First peer-reviewed AIEX MCSGP for therapeutic siRNA. Yield improved from 80% to 93% on a sugar-conjugated siRNA sense strand — software-aided method development enabled fast batch-to-MCSGP transfer. Throughput increased 87%.
Weldon et al. Org. Process Res. Dev. 2025, (Open-Access)
Proof-of-concept MCSGP for AAV2 polishing. Full capsid content increased from 30% to 68% (ddPCR) after six cycles — with +20.6% yield, +23% productivity, and 27% reduced buffer consumption vs batch AEX. AutoPeak® PAT validated against cryo-TEM and ddPCR.
Müller et al.
Biotechnol. Bioeng. (Open-Access)
Application notes, peer-reviewed papers, process guides, datasheets, and recorded webinars — searchable by application, technology, product, or service.
Additional viral validation studies for CaptureSMB validate a surrogate batch model that accurately predicts virus clearance in continuous capture operations.
Model-based approaches for twin-column continuous capture process design establish systematic methodology for CaptureSMB implementation.
Viral validation studies conducted under cGLP guidelines for CaptureSMB demonstrate comparable virus clearance to batch processing and establish regulatory-compliant validation approaches.
CaptureSMB scale-up from laboratory to manufacturing scale establishes engineering principles for continuous capture process transfer.
Purification is where oligonucleotide yield is lost, and the synthesis has to be sized to cover it. Converting a reversed-phase batch method for a GalNAc-conjugated gapmer to twin-column MCSGP lifted recovery from 52.7% to 91.6% at the same purity — enough to shrink the synthesis step by 42.5% for the same daily output.
An established anion exchange batch method for a conjugated siRNA sense strand, converted to continuous twin-column MCSGP: 13 cycles, 27 product elutions, and yield up from 80% to 93% at unchanged purity — plus a software-aided route from batch chromatogram to running method.
Continuous chromatography is already in production use, but there was no published account of how to validate it for a regulatory filing. This study provides one, working through Process Characterization and Performance Qualification for MCSGP on commercial-scale Bivalirudin purification: 34 parameters assessed, four tested, one critical.
Green solvents have always cost the peptide industry recovery. This study shows the loss is a property of batch chromatography, not of the solvent: run the same green eluent counter-currently and the yield comes back.
YMC ChromaCon Chromatography Newsletter.
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