Technical library

For a list of peer-reviewed articles our products have been cited in, check out the publications page.

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Application Notes

		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。
		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

		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.
		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.