iCE webinars

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Meet Maurice — One-stop cIEF and CE-SDS For Your Biologics

December 8, 2016
Scott Mack, Senior Scientist, ProteinSimple
Jiaqi Wu, Principal Scientist, ProteinSimple

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Meet the Fastest and Smartest CE, Maurice

March 3, 2016
Annegret Boge, Director, Science, ProteinSimple
Jiaqi Wu, Principal Scientist, ProteinSimple
Alpana Prasad, Product Manager, iCE, ProteinSimple

Need cIEF and CE-SDS data for your biologics? Maurice does it all—mAbs, ADCs and vaccines. He'll even give you data on their variants. Just pop in one of his ready-to-go cartridges, drop in your sample vials or a 96-well plate, and hit start.

Maurice is the new Advanced CE platform. He delivers the same high quality results as the iCE3 system and adds the Native Fluorescence (NF) mode of detection that delivers 4x higher sensitivity compared to absorbance mode.

With the new friendly software, Compass for iCE, Maurice is a pro at size-based separation and his CE-SDS application gives you a baseline resolution of reduced non-glycosylated and glycosylated IgG heavy chain in just 25 minutes. He also features a dedicated cartridge for each application to prevent cross-contamination and his simple workflow from set-up to data analysis reduces variability.

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A Streamlined Approach to icIEF Method Development

June 1, 2016
Richard Smart, Senior Associate Scientist, Technical Development, Biogen

Determination of isoelectric points and charge isoforms are critical steps in protein characterization for biopharmaceutical and vaccine development. Biogen's Analytical Development (AD) group applied Quality by Design (QbD) and Computer-Aided Design of Experiments (DoE) approaches for icIEF assay development and qualification of a challenging IgG molecule. This innovative computer-aided DoE and a 96-well plate coupled with automated sample preparation enabled the AD group to meet development timelines for multiple products.

In the webinar, Richard will present the DoE principles and approach to icIEF method development and optimization. He will also discuss the software upgrades to assist in high throughput method development, including automated sample preparation.

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Analysis of Maytansinoid ADCs by Imaged Capillary Isoelectric Focusing (icIEF)

December 8, 2015
Karan K. Shah, M.S., Analytical and Pharmaceutical Sciences, ImmunoGen, Inc.

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Method Development and Transfer with iCE: A QC Experience

June 18, 2015
Joan Garrison, Scientist, QC Method Transfer, Cook Pharmica LLC
Scott Mack, Senior Scientist, ProteinSimple

Determination of isoelectric points and charge isoforms are critical steps in protein characterization for biopharmaceutical and vaccine development. Charge variants or heterogeneity commonly occurs as a result of post-translational modification including glycosylation, deamidation, sialylation and oxidation. These changes can affect biological activity and drug stability. In this webinar, we will present examples of method development and transfer for Charge heterogeneity analysis of biopharmaceutical products using iCE platform focusing on specific requirement of a QC environment. We will also provide a brief overview on robust method development on iCE3.

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Rapid and Easy Charge Heterogeneity

November 12, 2014
Scott Mack, Senior R&D Scientist, ProteinSimple
Dave Gervais, Senior Process Scientist, Public Health England

Determination of protein isoelectric points and charge isoforms are critical steps in protein characterization, biopharmaceutical and vaccine development. Charge variants commonly occur as a result of post translational modification including glycosylation, glycation, amidation, sialylation and oxidation. These changes can affect biological activity, patient safety, and drug stability. The iCE3 provides a rapid 10 minute platform method for charge heterogeneity that can be utilized for a wide variety of samples such as purified and recombinant proteins, antibody drug conjugates, vaccines, and viruses. In this webinar Scott Mack, Senior Scientist at ProteinSimple and David Gervais, Senior Process Scientist, Public Health UK will present how iCE can be used for charge heterogeneity analysis of difficult to analyze proteins.

Learning Objectives:

  • How the ProteinSimple iCE system can resolve deamidation, C-terminal lysines, sialylation, oxidation, glycoslyation glycation and any other change to the protein that will result in a change to the pI of the protein
  • How the iCE system can be implemented across the entire pharmaceutical process, from formulation development and optimization, to commercial quality control (QC) release and stability activities
  • How the iCE platform can perform free solution IEF in a capillary column (cIEF) and detect focused protein zones in 10 minutes
  • How this system can be applied across the therapeutic protein development process from discovery through formulation and process development

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Easy and Rapid Analysis of Antibody Drug Conjugates and Highly Hydrophobic Proteins

June 26, 2014
April Xu, Ph.D., Sr. Principal Scientist, Pfizer
Susan Darling, Director, Product Management iCE and MFI, ProteinSimple
Scott Mack, Sr. Scientist, ProteinSimple

Automated methods for charge heterogeneity detection such as imaged capillary isoelectric focusing (icIEF) have been widely adopted by the biopharma industry. These techniques provide rapid high resolution charge variant separation with easy method development and minimal start up time. Imaged cIEF also offers the ability to analyze complex antibody drug conjugates (ADC) and highly hydrophobic peptides and proteins.

In this webinar, Susan Darling will provide an overview of the iCE technology followed by April Xu, Ph.D., Senior Scientist at Pfizer who will present the application of cIEF to enhance process understanding and product characterization for a lysine chemistry-based ADC as well as for monitoring the drug load distribution in final drug product. Scott Mack will review new strategies for analyzing highly hydrophobic proteins such as high density lipoproteins and how to reduce aggregation and hydrophobic interactions during analysis.

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Easy and Simple Charge Heterogeneity Analysis

April 24, 2014
Scott Mack, Senior Scientist, ProteinSimple
Jiaqi Wu, Principal Scientist, ProteinSimple
Susan Darling, Director, Product Marketing, ProteinSimple

Analyzing charge variants of therapeutic proteins is critical for development and manufacture of a safe, efficacious drug. Types of charge variants include deamidation, formation of N-terminal pyroglutamate, aggregation, isomerization, sialylated glycans, antibody fragmentation, and glycation at the lysine residues. In some cases, such changes affect binding, biological activity, patient safety, and shelf life.

Automated methods for charge heterogeneity detection such as imaged capillary isoelectric focusing (icIEF) have been widely adopted by the biopharma industry. These techniques provide rapid high resolution charge variant separation with easy method development and minimal start up time.

In this webinar we will present a rapid and easy workflow for icIEF method development on the iCE3. The presenters will provide a step-by-step guide for optimizing separations along and review critical parameters for ensuring long term robustness of the assay. Following these simple procedures combined with a 10 minute analysis time allows for robust methods development in an afternoon.

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10 Minute Charge Heterogeneity Analysis for Development and Quality Control of Biopharmaceuticals

November 12, 2013
Carrie Anderson, Senior Scientist, Merck
Karan Shah, Senior Research Associate, Immunogen
Scott Mack, Senior Scientist, ProteinSimple

Determination of protein isoelectric points and charge isoforms are critical steps in protein characterization and biopharmaceutical development. Charge variants commonly occur as a result of posttranslational modification including glycosylation, glycation of lysine residues, amidation, sialylation, and oxidation. These changes can affect biological activity, patient safety, and drug stability.

In this webinar Carrie L. Anderson, Senior Scientist, Vaccine Analytical Development, Merck & Co. will present the wide range of applications for icIEF in biopharmaceutical development and demonstrate how icIEF increases the efficiency of process and formulation development. Karan Shah, Senior Research Associate, Immunogen will review the challenges of analyzing antibody drug conjugates (ADC) and present how icIEF allows them to monitor both the charge heterogeneity profile and quantitate the amount of unconjugated antibody present in a ADC sample.

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Charge Variant Analysis for High Throughput Process Development

March 26, 2013
Dr. Simon Briggs, In-Process Analytics Team, UCB Pharma
Scott Mack, Senior Develpment Scientist, ProteinSimple

Process development requires suitable analytical methods which are able to demonstrate process robustness for both upstream or downstream processes. The use of QbD and the increasing numbers of samples which require analysis has meant that we have had to employ new and higher throughput technologies in order to cope. One of the most troublesome assays to perform is charge variant analysis by CEX-HPLC which has been notoriously time consuming to perform and lacks the robustness required for high throughput applications. Utilizing the iCE3 with an Alcott autosampler we have been able to utilize the high throughput sampling of the device and be assured that the system delivers well controlled and reliable results. We will demonstrate comparability and robustness of the technique applied to analysis of process development samples.

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The iCE Platform, an Excellent Tool for Fast and Efficient Process Development, Product Control and Product Comparability

September 26, 2012
Chantal Felten, Ph.D.
David Michels, Ph.D., Genentech
Zoran Sosic, Ph.D., Biogen-Idec

In today's competitive biopharmaceutical environment, fast and efficient product and process development is critical to a new drug’s success. One of the key product attributes monitored as an indicator for both process and product control is the Charge Variant Profile (CVP).

Combining automation, fast analysis times, high resolution separation and a robust instrument platform has allowed iCIEF to become the tool of choice for charge variant analysis throughout the product's lifecycle. This presentation will review critical analytical activities during drug development and emphasize the impact of iCIEF on overall development resources.

Dr. Felten will be joined by fellow CE industry experts David Michels, PhD (Genentech) and Zoran Sosic, PhD (Biogen Idec) who will discuss their experiences implementing iCIEF in their organizations.

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Secrets of iCE Method Design for Protein Therapeutics

March 27, 2012
Dr. Jiaqi Wu, Principal Scientist, ProteinSimple
Scott Mack, Field Applications Scientist, ProteinSimple

Isoelectric Focusing (IEF) has proven to be a powerful tool for determination of charge heterogeneity of therapeutic proteins. Since its introduction, iCE has become the preferred method for charge heterogeneity analysis by the biopharmaceutical industry, generating critical data for regulatory submissions and manufacturing lot releases. Presented in this seminar are analyte and instrument-based considerations crucial to achieving the maximum performance on the iCE. By reviewing the fundamentals of isoelectric focusing and the critical parameters in developing robust separations, the presenters will provide a step-by-step guide for optimizing separations.

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