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