Below are presentations & articles which describe the power and efficiency customers achieve using Fusion QbD.
Mapping Key Elements in the ICH Q14 and USP <1220> Guidances to an Enhanced Workflow for Analytical Procedure Development.
Controlling the elution order of insulin and its analogs in sub-/supercritical fluid chromatography using methanesulfonic acid and 18-crown-6 as mobile phase additives.
(Journal of Separation Science, 2023; 46:2300520)
Beyond Column Screening: Chiral Method Development for Small Molecules using DOE Principles.
Impacts of USP Modernization Initiatives on Analytical Development for Drug Products.
Using design of experiments to optimise SEC method conditions for proteins.
(European Pharmaceutical Review, Volume 27, Issue 05, October 2022)
Stability-indicating method development for quantification of bromopride, its impurities, and degradation products by ultra-high performance liquid chromatography applying Analytical Quality by Design principles.
(Journal of Pharmaceutical and Biomedical Analysis, 205 (2021) 114306)
Ginsenoside Contents in Ginseng: Quality by Design-Coupled Two-Dimensional Liquid Chromatography Technique.
(Journal of Chromatography Science, 2021, 1–9)
Ultra high-performance liquid chromatography method development for separation of formoterol, budesonide, and related substances using an analytical quality by design approach.
(Journal of Pharmaceutical and Biomedical Analysis, Volume 193, 30 January 2021, 113729)
Development of a Stability-Indicating Analytical Method for Determination of Venetoclax Using AQbD Principles.
(ACS Omega 2020, 5, 17726–17742)
Experimental design applied in UPLC-DAD method development of Malpighiaceae species extracts and metabolite identification.
Successful Modernization of a USP Monograph Method using Fusion QBD Software resulted in an Optimized LC/MS Method and Eliminated the Need for a Separate GC Method.
Integrating and Automating the Use of PDA and MS Data in LC and LC/MS Method Development.
Integration of MS and UV Data for Peak Tracking in HPLC Method Development.
(Chromatography Today, February/March 2019)
Ultra high performance liquid chromatography method development for separation of omeprazole and related substances on core‐shell columns using a Quality by Design approach.
[Modernization of the USP Monograph method for Omeprazole and related substances using Fusion QbD]
(Journal of Separation Science, November 2019)
Increasing Productivity for Biopharmaceutical Analysis — Approaches for Chromatography Development.
[SEC Method Development using Fusion QbD Software with the Acquity H-Class AutoBlend PlusTM Technology]
(Waters Webinar, November 2018)
How To Use QbD Software To Improve An Existing Identification Method.
[Modernization of the USP Monograph method for Human serum albumin (HSA) using Fusion QbD]
(Pharmaceutical Online, November 2017)
Development of an SFC Method for QC of Carbamazepine using Fusion QbD.
Use of Fusion QbD for Automated Method Screening for Biotherapeutics.
Fusion QbD and the ‘Perfect Storm’ of Technologies Driving QbD-aligned LC Method Development
(Chromatography Today, August/September 2015)
Development and validation of a rapid ultra-high performance liquid chromatography method for the assay of benzalkonium chloride using a quality-by-design approach.
(Journal of Chromatography A, 1413 (2015) 22–32)
FDA-EMA Collaborative Research on Analytical QbD — Screening and Optimization Designs to Improve Method Performance and Robustness.
A QbD with Design-of-Experiments Approach for Development of a State-of-the-Art UPLC Purity Method for Carbamazepine.
(Journal of Liquid Chromatography & Related Technologies, Volume 37, 2014, Issue 18)
Improved quality-by-design compliant methodology for method development in reversed-phase liquid chromatography.
(Journal of Pharmaceutical and Biomedical Analysis, Volume 84, October 2013, Pages 215–223)
Newer Developments in HPLC Impacting Pharmaceutical Analysis: A Brief Review.
(American Pharmaceutical Review, Volume 16 Issue 4, May/June 2013)
Evaluation of Fusion QbD system – A QbD Approach to Method Development and Robustness Studies (SEC-LC and CEX-LC).
QbD LC Method Development Using FMD Software.
Quality by Design (QbD) Based Development of a Stability Indicating HPLC Method for Drug and Impurities.
(Journal of Chromatographic Science, Volume 49, July 2011)
A Quality-by-Design Methodology for Rapid LC Method Development, Part III.
(LCGC North America, Volume 27, Number 4, April 2009)
DOE-based Study of Separation of Organic Acids using HILIC.
(Chromatographia 2007, 66 August (Number 3/4))
Fusion LC Method Development has been in use for a number of years, and customers have successfully applied FMD to develop and optimize LC methods according to QbD guidelines for a wide variety of sample types, including small molecules, peptides, proteins, and nucleotides. Fusion QbD supports a wide range of chromatographic techniques for these samples, including reversed phase, normal phase, ion exchange, HILIC and Chiral separations, and it has never failed to identify an improved method which meets performance requirements.
Below are application notes which demonstrate the power and efficiency of Fusion QbD for chromatographic methods development.
Development of a robust pH gradient method for mAb charge variant analysis using CIEX with Fusion QbD
Automated method optimization for drug-to-antibody ratio determination using HIC with Fusion QbD
Separation of a Critical Pair of N-Glycans using a Quality by Design (QbD) Approach.
Rapid Development and Validation of a Size Exclusion Chromatography Method Using Fusion QbD.
QbD Based Method Development — Agilent Infinity II UHPLC and ISET Operating Under Empower 3.
QbD Based Development of a Robust Peptide Mapping Method for a Therapeutic Monoclonal Antibody (mAb).
QbD Based UHPLC Method Development with Seamless Method Transfer to HPLC Using Intelligent System Emulation Technology
Automated QbD-Based Method Development and Validation of Oxidative Degraded Atorvastatin
A QbD Approach to Stability Indicating Method Development for Linagliptin Drug Product.
QbD Optimization of an Impurities Method using Peroxide Degraded Ziprasidone.
A QbD with Design-of-Experiments Approach to the Development of a Chromatographic Method for the Separation of Impurities in Vancomycin.
Accelerated, Automated Development of Robust LC Methods within a QbD Framework.
Using a Design of Experiments Approach to Develop Fast LC Methods for Automated Scale-up to Preparative Chromatography of Sulfa Drugs.
Rapid development of an LC method for separating high molecular weight degradants from a biopharmaceutical product using an automated Design of Experiments (DOE) approach.
DOE-based Study of Separation of Organic Acids using HILIC.
S-Matrix develops advanced and innovative Quality by Design software. Our Fusion QbD Software Platform incorporates expert-system guided statistical Design of Experiments (DOE) and multivariate data analysis/modeling technologies within a Quality by Design (QbD) framework.