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Page 1: Analytical Technique Comparisons using LINKlumetics.com/wp-content/uploads/2020/01/Lumetics... · 2020. 1. 8. · Zetasizer), and SEC/cIEF (Empower). Analysis templates were developed

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Characterization and control of protein aggregationrequires the use of a wide range of analysis techniques.Transcribing, aggregating and comparing data frommultiple measurements with different size ranges,resolutions, and output formats is very labor intensive.Recent advancements in data management andvisualization technologies now allow for automated dataextraction directly from analytical equipment measurementfiles, and automated processing of this data for detailedorthogonal and complimentary technique comparisons.

Analytical Technique Comparisons using LINKC. Merchant, Ph.D., D. Thomas

LINK was used to automatically transcribe measurementdata directly from equipment measurement files into acentralized database. Sample information exemplifying atypical stability study, such as storage time point andstorage temperature, were parsed from each data file.LINK Analysis templates for the purpose of technologycomparisons were constructed, and updated in real-timewith each data import.

Sample datasets were made available from FlowMicroscopy (MFI), Light Obscuration (HIAC), RMM(Archimedes), NTA (NanoSight), DLS (DynaPro,Zetasizer), and SEC/cIEF (Empower). Analysis templateswere developed for the purpose of comparing:

a) Particle Counting Techniquesb) DLS Techniquesb) MFI and HIAC – Stability Studyc) MFI and FlowCAM Sub-Populationsd) Archimedes Sub-Populationse) Particle Counting and DLSf) Particle Mass g) Disparate Techniquesh) High-Throughput EPD Summaries

Introduction

Methods

It was found that the LINK data management and analysistool provided direct comparison of orthogonal andcomplimentary analytical techniques in a fully automatedfashion, dramatically improving the speed of analysis andeliminating the possibility of transcription errors. Futurework will involve exploring how multi-variate datavisualization tools and statistical analysis within the LINKtool might further contribute to the characterization andcontrol of protein formulations.

Conclusions

Dashboard 1 shows particle counting techniques for user-specified size ranges. Particle images are included, whereapplicable.

Dashboard 2 compares DLS techniques and providessummary statistics of any parameters measured byequipment software.

Dashboard 3 illustrates particle counting techniquecomparisons for USP 788/787 size ranges, as a function ofstability study parameters (e.g. time, temp), highlightingtrends in concentration between different techniques.

Dashboards 4 and 5 permit comparison of multiple user-defined subpopulations (e.g. silicone oil or proteinpopulations) based on particle morphology or particledensity/buoyancy assumptions.

Dashboard 6 compares particle counting techniques andDLS using particle volume distributions as a function ofsize. Particle shape and density assumptions are required toconvert count to volume %.

Dashboard 7 highlights the mass of the particle/aggregatepopulation, vs. particle count.

Dashboard 8 compares entirely disparate techniques, such asparticle formation detected by counters vs. changes in SECchromatograms.

Dashboard 9 permits summarization of high-throughput wellplate experiments, or specific EPD studies.

Discussion

Dashboard 1: Particle Counting Techniques Dashboard 2: DLS Techniques Dashboard 3: MFI and HIAC – Stability Study

Dashboard 5: Archimedes Sub-Populations Dashboard 6: Particle Counting and DLSDashboard 4: MFI and FlowCAM Sub-Populations

Dashboard 7: Particle/Aggregate Mass Dashboard 8: Disparate Techniques Dashboard 9: High-Throughput EPD Summaries