Volume 1, Issue 4, Summer 2025
Table of Contents
When the iCE3 System was introduced in 2012, it was rapidly adopted for its unparalleled icIEF performance for measuring the charge heterogeneity in biotherapeutic molecules. However, significant improvements and additions led to the development of the Maurice systems, which were built on the same iCE technology. As Maurice and MauriceFlex instruments started to be increasingly validated within the industry and widely implemented, the iCE3 platform was discontinued in June 2022, with full instrument service and support available until June 30, 2029.
Learn how icIEF became the gold standard for charge heterogeneity analysis and the numerous benefits that the Maurice platform offers over iCE3.
- Get the latest on the world of Biotech IPO’s through this comprehensive list by Biopharma Dive
- Famed COVID-19 vaccine-maker Moderna sees positive results with an mRNA vaccine for the flu. Read the full story here.
- To make treatment more accessible, FDA slashes Risk and Evaluation and Mitigation Strategies (REMS) requirements for blood cancer-related CAR-T cell therapies. Read more here.
- New biologic manufacturing facilities are opening on the East Coast, a bonus for some job opportunities and faster production. Read more here.
- Onshoring and affordability projects related to drug development and manufacturing have the chance to be fast-tracked with the FDA’s national priority program. Get the full story here.
Brochure: iCE3 Transition Support
Brochure: iCE3 Transition Support
This 8-page brochure provides valuable information to help make the transition, including key publications, summaries from customers who have completed their bridging studies, bridging study models, timelines, FAQs and reagents that will still be available after the iCE3 instrument service support is discontinued.
Global iCE3 and Maurice Data Comparability Study
Global iCE3 and Maurice Data Comparability Study
This spotlight describes a global multi-company (19 companies/ 20 labs) icIEF study that demonstrates the comparability of iCE3 and Maurice. Both systems produce identical apparent pI values for the main isoform and comparable relative peak areas for the acidic, main, and basic isoforms for the NIST mAb and rhPDL1-Fc. Full details were published in the Electrophoresis Journal in March 2022.
App Note: iCE3 and Maurice Data Comparability Evaluation
App Note: iCE3 and Maurice Data Comparability Evaluation
This application note demonstrates the data comparability between iCE3 and Maurice and showcases the charge isoform characterization of three molecules: erythropoietin (EPO), monoclonal antibody 11 (mAb11). Each of these molecules was analyzed on both platforms for charge isoform peak quantitation and pI reproducibility using absorbance detection.
See the recently published Boehringer Ingelheim study in the journal of Electrophoresis: Universal Study Design for Instrument Changes in Pharmaceutical Release Analytics
Save the date: iCE3 Virtual User Meeting
All current iCE3 Users are invited to join us at our upcoming Virtual User Meetings. There are two broadcast times to accommodate users in both Europe and North America.
Our featured speakers, Anne Ries (Boehringer Ingelheim) and John Orlet (Pfizer), have been part of successful bridging studies and will share their experience in instrument changes, bridging study designs and results, technical tips, and best practices. In addition, learn about the data comparability between iCE3 & Maurice, along with the additional capabilities Maurice platforms offer. The talks will be followed by live panel discussions with industry experts (including Seth Madren from Biogen and Sylvia Caciolli from Lonza) to answer any questions you might have about planning for and successfully transitioning from the iCE3 to Maurice platforms.
Wednesday 24 September
Save the Date: Speeding up Biotherapeutic Charge Variant Analysis
As sample numbers increase, scientists are seeking strategies to improve productivity and throughput for charge variant analysis. In this webinar hosted by Drug Discovery Networks, Dr. Michael Grasso (Merck) and Will McElroy (Bio-Techne) will present the development and implementation of the SupersonicIEF method, which significantly reduces overall analysis time while preserving data quality, offering a practical solution for accelerating biotherapeutic characterization.
Tuesday 16 September
Join us at one of our upcoming User Meetings or Conferences to learn about the latest advancements in biotherapeutic characterization. Or let us provide lunch or snacks at your site while sharing our Biologics Bitesize Tech Talks on the topics of most interest to your lab.
- The Bioprocessing Summit (August 18-21)
- CE Pharm (September 7-10)
- Philadelphia, PA Instrument User Meeting (September 25)
- Research Triangle Park, NC Instrument User Meeting (October 7)
- Boston, MA Instrument User Meeting (October 21)
- San Diego, CA Instrument User Meeting (November 6)
Introducing: Biologics Bitesize Tech Talks
Do you want to learn about the latest applications for the Maurice and MauriceFlex platforms - but don't have much time? We’re happy to host lunch or a break at your convenience to discuss the topics of most interest to your lab. Choose from our menu of 15-minute bitesize talks to discover what’s new in the areas of biomolecular-specific analysis, icIEF fractionation, CE-SDS, Gene Therapy, and more!
Choose from a full menu of topics
Bio-Techne now offers four monoclonal antibody U.S. Pharmacopeia (USP) Reference Standards (IgG System Suitability, mAb 001, mAb 002, and mAb 003) to overcome the limited availability of consistent, highly characterized mAb standards and to provide a range of reference products with different physicochemical properties. For Gene Therapy manufacturing and QC, AAV8 Empty/Full controls are also available.
Access these resources
- Flyer: USP mAb Reference Standards
- Tech Note: Charge Variant Analysis of USP Monoclonal Antibody Reference Standards using icIEF
- App Note: Equivalency Data for USP <129> using CE-SDS
- On demand Webinar: Utilizing USP Standards and Tools to Support Development of Monoclonal Antibodies and Gene Therapy Products
Optimizing your iCE3 transition experience
In her training series “Technical Tips from Monica Tyagi,” Dr. Tyagi discusses some simple but important steps to facilitate your transition from the iCE3 instrument to the Maurice platforms. She shares data comparability results from key publications, bridging study summaries and models, example timelines, hands on differences between iCE3 and Maurice systems, frequently asked questions (FAQs), and more.
Read our spotlight article on Xiaoping He, Pfizer (retired)
“The key advantages of Maurice vs ICE3 platforms are:
- Very intuitive and easy setup both hardware and software, extremely user friendly for running assay and system maintenance
- Direct data acquisition bridges the compliance gap of data integrity
- Native fluorescence features increased detection sensitivity 3-20 folds, making it possible for low abundance sample analysis
- No new method development necessary for existing iCE3 users, simply adopt the iCE3 method onto Maurice when using UV 280 detection
- Capability of icIEF charge and CE-SDS size analyses with one instrument
- [For MauriceFlex specifically]: Allows fraction collection of separated charge species for subsequent analysis including MS characterization for intact protein structural identification, peptide mapping for more detailed study on post-translational modification (PTM) analysis, and potentially potency assay for degraded charge species of stability samples to gain insight on charge related CQAs."
Be a Winner
