iCE technical library

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Application Notes

		Turbo CE-SDS™アッセイ(新製品)で時間とコストを節約しましょう	[概要表示]
		このアプリケーションノートでは新発売のTurbo CE-SDSカートリッジをMauriceで用いると、蛍光標識を必要とせず、タンパク質のサイズと純度のCE-SDSアプリケーションを高速ハイスループット（還元型サンプルは5.5分、非還元型サンプルは8分）で行い、タンパク質の直接検出と高品質のデータを迅速に取得することを示します。Turbo CE-SDS アッセイの高い再現性、分離の直線性、幅広いダイナミックレンジ、優れた検出限界 (LOD) も示します。以前から広く用いられているMauriceのCE-SDSアプリケーションに加え、CE-SDSアプリケーションのスループットの課題を解決し、バイオ治療薬研究開発段階から分析開発やQCまで、ステップごとにニーズのあったタンパク質のサイズと純度分析を1台で行えるようになりました。
		Empower®でpIマーカーのパラメーター設定ガイド	[概要表示]
		このテクニカルノートでは、サンプルのpI値を簡単にそして正確に測るために、Empower® Instrument MethodでpIマーカーを定義する一般的なガイダンスを提供します。
		遺伝子治療用アデノ随伴ウイルス（AAV）タンパク質のicIEF分析	[概要表示]
		このアプリケーションノートでは、AAVプロダクトの安定性と同一性をより理解するためにAAVベクターの電荷不均一性を特性評価する方法を実証します。Mauriceの電荷不均一性解析はAAVの安定性のモニタリングに使用できることも示します。また、熱変性したAAVプロダクトに95°Cで5分間ストレスを与え電荷不均一性解析を行ったところ、酸性側のピークが増加したため、酸性側のピークが増加したAAVは有効性や安全性に悪影響を及ぼす可能性を示唆しています。
		Get USP <129> Equivalent Data with Maurice CE-SDS	[概要表示]
		In this application note we demonstrate the comparability of the Maurice CE-SDS PLUS method with the USP<129> protocol for analysis of monoclonal antibodies. Using USP’s IgG System Suitability Reference Standard, the USP <129> method was first run on Maurice to determine ease of method transfer, followed by optimization of the Maurice protocol for comparison with USP <129>.
		Comparing SDS-PAGE with Maurice CE-SDS for Protein Purity Analysis	[概要表示]
		In this Application Note, learn how Maurice CE-SDS outperforms SDS-PAGE for protein purity analysis.
		iCE3 and Maurice Data Comparability Evaluated Using Three Biomolecules	[概要表示]
		The iCE platform has been the gold standard for monitoring charge heterogeneity of biological products for more than 20 years. When we introduced Maurice, the next-generation iCIEF instrument that leverages the iCE imaged cIEF technology, we ensured that our customers achieved the same performance and data quality. Designed to simplify the workflow, Maurice significantly decreases instrument setup time and minimizes potential sources of error through its pre-assembled cartridge that contains the capillary and associated system fluidics. This application note is intended to help assure our customers of the data comparability between iCE3 and Maurice and showcases the charge isoform characterization of three molecules: erythropoietin (EPO), monoclonal antibody 11 (mAb11), and anti-α1-anti-trypsin. Each of these molecules was run on both iCE3 and Maurice to compare charge isoform peak quantitation and pI reproducibility using absorbance detection.
		Developing Biosimilars of Tocilizumab? Win the Race Against Time with Maurice	[概要表示]
		A growing demand for biosimilars has only added to the fierce competition of drug development. On such a front, time is of the essence and there is an urgent need for robust analytical tools for various stages of biosimilar development. This application note discusses the use of a bi-functional analytical tool, Maurice, in the stability study of Actemra® (Tocilizumab). As a popular monoclonal antibody used for treating rheumatoid arthritis, and more recently, in the treatment of COVID-191, Tocilizumab has several biosimilars in the pipeline of various biopharmaceutical companies. In this study, we demonstrate how Maurice accurately detects and quantitates changes in Tocilizumab under various stress conditions, thus making it a valuable and easy-to-use tool for comparability assessments in biosimilar development.
		Powering Up Maurice with Waters Empower® Software Application Note	[概要表示]
		Utilizing Waters’ Open Interface Portal (OIP) for multi-vendor hardware control, ProteinSimple’s Maurice Empower® Control Kit enables seamless control of the Maurice platform with all key functions preserved and with full regulatory compliance, including 21 CFR Part 11 controls for industry-leading security and data integrity.
		Assessing Your AAV Product Quality? Get the Confidence You Need With Maurice	[概要表示]
		Viral capsid content can impact gene therapy product efficacy and is therefore considered a Critical Quality Attribute (CQA) that must be properly evaluated during the development and manufacturing of AAVs. Traditional analytical tools such as transmission electron microscopy (TEM), analytical ultracentrifugation (AUC), and ion-exchange chromatography (IEX) can be used to characterize capsid content but are complex, labor-intensive, and pose challenges in data reproducibility, throughput, and scalability. In this application note, we show how imaged-capillary isoelectric focusing (icIEF) technology on Maurice can be used to characterize empty, intermediate and full AAV capsids at native and stability screening conditions, providing robust and reproducible data. With this, Maurice provides crucial data to aid in developing the right formulation for AAV therapeutics.
		コンピューターを利用した iCE電荷不均一性アッセイの開発\| Japanese	[概要表示]
		DOEのようなコンピューターの支援によるメソッド開発は、事前知識や実験結果を活用することで、メソッド開発のコストを明らかに削減します。このアプリケーションノートでは画像キャピラリー電気泳動を行い、どのようにピークの分離を改善するかを例に、アッセイ開発プロセスにおいて上手にDOEツールを運用する手助けとなることを目的としています。
		icIEF Analysis AAV Proteins for Gene Therapy - Japanese

		Computer-aided Assay Development for Charge Heterogeneity Analysis by iCE Japanese

		Waters™ Empower®ソフトウェアでMauriceをエンパワー\| Japanese	[概要表示]
		このアプリケーションノートでは、Empower®でMauriceをコントロールし、モノクローナル抗体の画像キャピラリー等電点電気泳動（cIEF）とCE-SDSデータの収集と解析を行います。cIEFデータを時間軸、吸光度、ピクセルを伴う3Dスペクトル(グラフ)で表示すると、一つの3D画像でタンパク質が収束する様子をより包括的に理解できます。
		Characterization of Adeno-Associated Viral (AAV) Vector Proteins Using Maurice CE-SDS - application note	[概要表示]
		Recent advances in vector engineering, delivery and safety have placed viral vector-based therapy at the forefront of gene therapy, with adeno-associated virus (AAV) being one of the most actively investigated. To support the rise of AAV vectors in the clinic, technological solutions that afford robust quality control assays are essential for implementing Good Manufacturing Practice (GMP), meeting regulatory requirements and ensuring the clinical quality, safety and consistency
		icIEF analysis of Adeno-Associated Virus (AAV) proteins for Gene Therapy App Note	[概要表示]
		icIEF analysis of Adeno-Associated Virus (AAV) proteins for Gene Therapy App Note
		CE-SDS Analysis of a NISTmAb Reference Standard Using Both Maurice and the SCIEX PA 800/PA 800 Plus	[概要表示]
		In this application note, we’ll show you how Maurice data compares against SCIEX PA 800 systems for reduced and non-reduced CE-SDS separation of a reference monoclonal antibody from the National Institute of Standards and Technology (NIST).
		Enhanced CE-SDS Analysis with Maurice’s CE-SDS PLUS System	[概要表示]
		Maurice’s CE-SDS application delivers speed, automation, reproducibility, and high-resolution data. The CE-SDS PLUS system preserves features and adds enhanced sample stability and data consistency.
		Application of Maurice CE-SDS for Biopharmaceutical QC Workflows

		Monoclonal Antibody Characterization by CE-SDS: Maurice Versus LabChip	[概要表示]
		In this application note, we compare Maurice™ against PerkinElmer’s LabChip® GXII Touch, a chip-based electrophoretic separation system. Under reduced and non-reduced conditions, we evaluate CE-SDS separation using a reference mAb from the National Institute of Standards and Technology (NIST). Maurice and LabChip are assessed for their performance on linearity, sensitivity, precision, reproducibility and resolution, with the technological approach, workflow and data quality outlined for easy comparison.
		Staying 21 CFR Part 11-compliant with Maurice and Compass for iCE	[概要表示]
		In this application note, we’ll hone in on the 21 CFR Part 11 tools integrated into Compass for iCE for batch execution and data processing, plus audit trails and electronic signatures.
		Maurice, iCE3, and iCE280 Data Equivalency for cIEF Charge Heterogeneity Absorbance Assays	[概要表示]
		In this application note, we demonstrate data equivalency across iCE instruments by running multiple molecules across all three systems. Data equivalency between iCE280 and iCE3 systems using Alcott and PrinCE autosamplers has been demonstrated before, so we focused on comparing system quantitation and reproducibility using absorbance mode on iCE280-PrinCE, iCE3-PrinCE, and Maurice systems.
		Mixing it Up with Maurice's cIEF On-Board Mixing	[概要表示]
		In this application note, we compare the data collected on Maurice using both hand-mixed samples and samples mixed using the on-board feature.
		Mauriceのネイティブ蛍光検出による電荷異性体分析の改善\| Japanese	[概要表示]
		Mauriceの画像キャピラリー等電点電気泳動（cIEF）のネイティブ蛍光検出は、バックグラウンドが非常に低く、UVの吸収による検出に比べて感度が3〜5倍高いので、UV照射で検出する方法に比べ、より低い濃度のサンプルを用いて電荷不均一性分析を行うことができます。このアプリケーションノートでは、タンパク質が収束するにつれてタンパク質濃度が高濃度になり、沈殿・凝集しやすいタンパク質を用いてcIEFを行っても、ネイティブ蛍光検出することで、可溶化剤として知られる尿素濃度を減らす、もしくは完全に取り除いてもタンパク質は沈殿・凝集することなくアッセイを行うことができることを示します。
		Sizing-up IgG with Maurice’s CE-SDS Application	[概要表示]
		If you’re in the biopharmaceutical industry, you’re probably using monoclonal antibodies (mAbs) routinely as therapeutic products. So it’s always a good thing when you can find better assessment tools like CE-SDS for product characterization and purity. Maurice, the newest member of the iCE family, takes CE-SDS to the next level by giving you way more throughput with a lot less hassle.
		iCE3 and iCE280 Analyzer System Performance Comparison	[概要表示]
		iCE3 is the next-generation iCE280 and features a number of technical improvements for better system fluidics, systemto- system reproducibility, and improved 21 CFR Part 11 options. All improvements are designed for direct transfer of methods from iCE280. As a direct replacement for the iCE280 system it was a requirement that iCE3 and iCE280 have equivalent applications performance. This document demonstrates system performance of iCE3 in comparison to iCE280 for all system configurations. The comparability experiments were performed using the following instruments and assays.
		Simplifying Charge Heterogeneity Method Development with iCE3

		Achieving 21 CFR Part 11 Compliance with the iCE3	[概要表示]
		This guidance defines the requirements for GMP compliant electronic records and signatures including procedural controls such as training and standard operating procedures as well as software technical controls to maintain data security.
		Computer-aided Assay Development for Charge Heterogeneity Analysis by iCE	[概要表示]
		Unlike chemically synthesized drugs, protein therapeutics are a dynamic heterogeneous mix of active compounds1. Due to their complexity, analytical techniques like isoelectric focusing have become indispensable tools in evaluating biologic preparations. The resulting surge in charge isoform analysis has led to major advances in instrumentation, such as Imaged Capillary Electrophoresis (iCE�)2 . However, to obtain the full benefit from improved instrumentation requires the coinciding development of robust assays. Initially implemented in biopharmaceutical manufacturing, the holistic process characterization philosophy known as Quality by Design (QbD) has the potential to transform assay development3, 4, 5. Proper adaptation of these techniques will provide a tremendous benefit to the robustness and predictability of assay performance. Key to QbD is comprehensively gauging the effects of process inputs on critical to quality (CTQ) attributes of the output3. To this end, the Design of Experiments (DOE) methodology has proven itself to be a highly efficient tool in modeling the relationship between input and output. Though statistical analysis packages such as SAS JMP and Minitab� have lowered the computational barriers to executing DOE, generating meaningful results still requires a working knowledge of the model building process. The goal of this note is to promote the successful application of DOE tools in the assay development process by offering a stepwise example. The road map contained in the following pages has purposely captured enough technical detail to provide a comprehensive reference guide for both the statistician and analytical biochemist. The subjects that will be covered include initial factor screening, construction of a central composite DOE, response surface modeling, assay optimization, model validation and assay performance.
		Faster and Easier Charge Heterogeneity Analysis with the iCE3	[概要表示]
		Three major usability improvements are now available for the iCE3 system. The new HT Cartridge improves resolution and run times by eliminating the need for methyl cellulose, saving up to 5 minutes per run when compared to the original FC cIEF Cartridge. Redesigned locking electrode arm hardware also reduces evaporation and minimizes cathodic drift, and updated software features allow automated pI calibration and data export.