The Intabio ZT system puts the critical information needed to make informed decisions on developability in the hands of biopharma scientists throughout the drug development pipeline. It cuts out information gaps and reduces risk to move biotherapeutic development forward faster.
Discover how your peers in the biopharma world are rewriting the rules of charge variant analysis, incorporating icIEF-UV/MS workflows on the Intabio ZT system into projects that are both challenging and routine.
Problem: Multiple CMC programs at Johnson & Johnson Innovative Medicine started to observe a dark brown color at viral inactivation stages.
Hypothesis: Reaction occurs in the bioreactor during the upstream process and remains throughout purification.
Goal: Characterize the components that contribute color and understand whether the process can be optimized to reduce those components.
Impact: This information was used to formulate a mitigation strategy to minimize business impact and was shared with colleagues in both upstream and downstream teams to optimize processes for future products.
Problem: During a project, the FujiFilm Diosynth Biotechnologies team identified unexpectedly high levels of acidic components. Traditional analytical approaches could not find the cause.
Hypothesis: Acidic species are mostly glycated species.
Goal: Leverage new technology to solve an ongoing problem.
Impact: A single icIEF-UV/MS run mitigated several months of inaccurate hypothesis formulation and prolonged experimentation.
Problem: A drug development team at AstraZeneca saw more peaks than expected on the standard icIEF assay for an ADC.
Hypothesis: Linker chemistry could be the contributing factor.
Goal: Identify the cause of charge heterogeneity on the ADC and determine whether the source is the mAb, payload or linker.
Impact: The ability to distinguish between antibody and payload related charge heterogeneity provides a new strategy for icIEF specification of ADCs.
Problem: During lead candidate selection, the Johnson & Johnson Innovative Medicine team saw an unusual unidentified split peak in the profile using the established icIEF screening method.
Hypothesis: The split peak is unidentified, but could potentially be attributed to trisulfide bonds or free thiol groups.
Goal: Determine the source of peak splitting and evaluate the suitability of clone candidates for production. Confirm the source of peak splitting by peptide mapping.
Impact: Disulfide mispairing was caught prior to molecule entry into cell line development.
Take full advantage of advanced characterization capabilities of the EAD enabled ZenoTOF 7600 system with simple conversion from icIEF-UV/MS to EAD based LC/MS
A 4x increase in sensitivity enables detection and confident identification of challenging proteoforms like deamidation.
Go deeper into the technology and workflows behind the Intabio ZT system with SCIEX experts.
Learn more about the importance of charge variant analysis in the development of biotherapeutics, and how the Intabio ZT system can significantly reduce the amount of time it takes to identify what is under the peak.
Only have 10 minutes? Catch up on the basics of the Intabio ZT system in this interview.
Discover a powerful, high-speed workflow for developability assessment during clone selection, manufacturing scale-up, and QC of protein therapeutics. Gain information for confident identification and localization of multiple critical PTMs utilizing the Intabio ZT system for in-depth subunit analysis.
Visit the ASMS hospitality suite from 2023 and take a virtual walk through of the Intabio ZT system.
Eliminate the guess work and monitor biologics at the intact-protein level, gaining insights into charge variant-associated quality attributes.
A high-resolution mass spectrometry solution that combines powerful MS/MS sensitivity, fragmentation technology and a step-change in data independent acquisition.
Purpose-built for the biopharmaceutical scientist for efficiency and quality, enabling multiple samples to be run in parallel.
Characterize therapeutic molecules with confidence with the kit-based system.
Pursue the end goal with confidence. Achieve the full picture and accelerate decisions with comprehensive characterization of biopharmaceutical charge variants.
Be clear on what you have and how much. Understand ADC drug loading profiles regardless of the inherent heterogeneity and high molecular weight of these molecules.
Achieve new heights in PTM analysis with confidence and speed. Define CQAs and streamline processes from early to late-stage development with in-depth peptide mapping solutions for next-generation protein therapeutics and standard mAbs.
Set the pace with confidence. Cell line monitoring and analysis solutions verify the identity, purity, and stability of lead candidates with high throughput strategies that are ready for automation.
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