GLOBAL STUDY DEMONSTRATES ICE3 AND MAURICE CAPILLARY ISOELECTRIC FOCUSING COMPARABILITY IN THE JOURNAL OF ELECTROPHERESIS

Rhea-AI Summary

Bio-Techne Corporation (NASDAQ: TECH) announced the publication of a global study in the Journal of Electrophoresis, assessing the comparability of its iCE3 and Maurice analytical platforms for charge heterogeneity analysis of therapeutic proteins. The study involved 19 sites across the US, Europe, and China, demonstrating excellent comparability with less than 1.02% standard deviation for charge variants and high precision for isoelectric point values. This advancement supports biopharmaceutical companies in transitioning to the Maurice system, enhancing its market presence and credibility in GMP quality control.

Positive

• Publication of a global study validates iCE3 and Maurice platform comparability.
• Standard deviations for charge variants are under 1.02%, indicating high accuracy.
• High precision isoelectric point values support product reliability.
• Strengthens Bio-Techne's position as a leader in protein charge analysis technology.

Negative

• None.

MINNEAPOLIS, May 25, 2022 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced the publication of a global study in the Journal of Electrophoresis: Global Intercompany Assessment of icIEF Platform Comparability for the Characterization of Therapeutic Proteins. This publication reports the findings of a multi-company study focused on the comparability of the iCE3 and Maurice instruments, two gold standard analytical platforms for charge heterogeneity analysis of therapeutic proteins. Bio-Techne pioneered the use of imaged capillary isoelectric focusing (icIEF) in 1999 with the iCE280, which was upgraded to the iCE3 in 2012. The introduction of the simpler to use Maurice system in 2016 not only made method design easier, but it also added Native Fluorescence and CE-SDS capabilities, expanding its utility. Transitioning to the Maurice system has been a priority for multiple biopharmaceutical companies. This comparability data will aid them and all companies in the transition to Maurice from the iCE3 platform.

In this study, 19 sites from the United States, Europe, and China participated, including 17 biopharmaceutical companies, one in vitro diagnostics company, as well as the National Medical Products Administration (NMPA) regulatory agency. Each site used both instruments to analyze a monoclonal antibody (NIST mAb) and the programmed death-ligand 1 fusion protein (rhPD‑L1-Fc). For each molecule, the electropherograms from both instruments were found to be comparable across all labs. The standard deviations for both molecules' charge variants were less than 1.02% on iCE3 and Maurice across the labs. Furthermore, the apparent isoelectric point (pI) values for the main isoform of the NIST mAb showed high precision across labs, and the relative standard deviation values on both instruments was less than 0.3%. Together, the data demonstrated excellent iCE3/Maurice comparability.

Bio-Techne's portfolio of iCE instruments is established as the 'gold standard' protein charge isoform analytical technology in the biopharmaceutical industry and is extensively implemented in GMP quality control (QC) release of commercial products. The ProteinSimple branded Maurice is Bio-Techne's next generation icIEF or iCE instrument. Establishing data comparability between the legacy iCE3 system and Maurice enables customers to confidently transition and take advantage of the additional capabilities Maurice offers. The data demonstrated in this latest study not only speaks to Maurice's performance, but also underscores the ease of method transfer from iCE3 to Maurice.

"We are grateful that the biopharmaceutical industry has adopted the iCE technology globally as the gold standard for measuring charge heterogeneity, a requirement from multiple regulatory agencies," commented Will Geist, President of Bio-Techne's Protein Sciences Segment. "The biopharmaceutical industry desperately requires new innovations to meet emerging patient and regulatory requirements, and we responded by introducing the next-generation iCE, Maurice, in 2016, which added Native Florescence and CE-SDS. Multiple companies requested comparability data between the legacy iCE3 and Maurice systems and we applaud and thank the more than 50 scientists who participated in the study recently published in the Journal of Electrophoresis to help them transition to Maurice."

About Bio-Techne Corporation (NASDAQ: TECH)
Contact: David Clair, Senior Director, Investor Relations & Corporate Development 
david.clair@bio-techne.com 
612-656-4416

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SOURCE Bio-Techne Corporation

FAQ

What was the focus of Bio-Techne's recent study published in the Journal of Electrophoresis?

The study focused on the comparability of the iCE3 and Maurice analytical platforms for charge heterogeneity analysis of therapeutic proteins.

When was the global study on the iCE3 and Maurice platforms published?

The study was published on May 25, 2022.

What were the findings regarding the iCE3 and Maurice platforms in the study?

The study found excellent comparability with less than 1.02% standard deviation for charge variants across participating labs.

How many companies participated in the comparability study of the iCE3 and Maurice instruments?

Nineteen sites participated, including 17 biopharmaceutical companies and one in vitro diagnostics company.

What is the significance of the comparability data for Bio-Techne's customers?

The comparability data enables customers to confidently transition from the legacy iCE3 to the Maurice system, which offers additional capabilities.