Micro-Flow Imaging webinars

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MFI as a Stability Indication Method

May 3, 2016
Daniel Peckman & Jonathon Ribera, Eurofins Lancaster Laboratories
Colin Merrifield, ProteinSimple

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Process Improvement for Research Use Only Protein Products with MFI

March 10, 2016
Colin Merrifield, Product Manager, MFI, ProteinSimple
Todd Geders, Scientist, Process Improvement, R&D Systems

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Advances in Particle Analysis: Biopharmaceutical Development Applications

November 5, 2015
Shawn Cao, PhD, Amgen
Yuling Li, PhD, MedImmune

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Keep Viscosity and Translucent Particles from Slowing Down Your Particle Analysis

April 21, 2015
Dan Berdovich, President, Micro Measuerment Laboratories
Angelica Olcott, Product Manager, MFI, ProteinSimple

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Particle Characterization Ensures Quality Therapeutic

February 26, 2015
Angelica Olcott, Product Manager, MFI, ProteinSimple

Sub-visible particles lie in wait during product development, ready to impair product stability when you least expect it. But how can you catch them before they act? In this webinar, Angelica Olcott will show how MFI can help you quickly screen for sub-visible particles during development and manufacturing. Sensitive image-based detection can quantitate silicone oil and translucent protein aggregates that older pharmacopeial methods, like LO, can miss. So if you're only using LO for USP <787>, you'll miss out on critical product quality and safety information.

Discussion Topics:

  • Quickly screen during development and manufacturing for sub-visible particles such as protein aggregates and silicone oil
  • Use particle classification to evaluate product quality and stability

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Simple Approaches to Monitoring Biopharmaceutical Purification with MFI

December 9, 2014
Aaron Noyes, Scientist, Purification Process Development, Pfizer
Angelica Olcott, Product Manager, MFI, ProteinSimple

Sub-visible particle analysis using micro-flow imaging is critical to monitor biopharmaceutical product quality and safety. Compared to older techniques which only provide particle size and count and can undercount, MFI also provides particle morphology. As a result, MFI can resolve complex particle types such as protein aggregates from silicone oil and other contaminants.

During purification of biologicals, complex particle environments are common. In this webinar, Aaron Noyes, Scientist at Pfizer, will show how MFI presents a fresh approach for characterizing biopharmaceutical production processes of mAbs and vaccines. Case studies focused on flocculation, precipitation, and filtration will demonstrate how measuring particle size, count and morphology can enhance process understanding, improve productivity, and ultimately, increase the robustness, of biopharmaceutical production processes.

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Changes to Sub-Visible Particle Regulations for Parenteral Biopharmaceuticals

September 17, 2014
Satish Singh, Ph.D., Research Fellow, Group Leader
Department of Biotherapeutics Pharmaceutical Sciences, Pfizer

Learning Objectives

  • How new regulatory guidelines for injected protein therapeutics address gaps in prior USP <788> for sub-visible particles (2-10 microns, >10 microns).
  • Strategies to apply the new criteria in formulation development, manufacturing, and quality control
  • Use of Flow Imaging analysis for sensitive detection of sub-visible particles, including protein aggregates at >2 microns

Overview

Current Pharmacopeial guidelines for monitoring subvisible particulates (SVPs) in therapeutic protein injections have expanded into new areas as USP <787> is provided as an alternative to <USP 788>. How will these new regulations impact your particle monitoring approaches? Join us for a webinar presentation by Dr. Satish K. Singh to learn more about these new guidelines and their impact.

During the follow-up discussion moderated by Angelica Olcott, real-world examples will exemplify how orthogonal techniques such as flow imaging have been implemented for sensitive detection of sub-visible particles.

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Micro-Flow Imaging Delivers the Need for Speed in Particle Classification

August 27, 2014
Angelica Olcott, Product Manager, MFI, ProteinSimple

Discussion Topics

  • Fast and easy setup for automated protocols with the BOT1
  • Create unique analysis filters to easily separate complex mixtures like silicone oil and protein
  • Analyze multiple sample runs or projects using one or more analysis filters

Overview

In this webinar, you will learn how the new MFI software simplifies and automates particle analysis. First we'll show you how easy and fast it is to create Bot1 batch protocols using a repeat step. Then using case study examples, you'll learn how to develop unique custom filters for analysis of complex particle samples containing silicone oil and protein aggregates. Once you have the custom filters we'll show you how to apply them to multiple samples instantaneously. Don't miss out! Discover how to analyze particles and protein aggregates in record time!

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Differentiation of Protein Particles and Silicone Oil Droplets by Micro-Flow Imaging

July 23, 2014
Daniel Weinbuch, Scientist, Coriolis Pharma
Angelica Olcott, Product Manager, MFI, ProteinSimple

Discussion Topics

  • Effective detection of sub-visible protein aggregates
  • Using MFI as a quality control method in a GMP environment
  • Particle classification of protein aggregates and silicone oil

Overview

Characterizing sub-visible particles, including protein aggregates, is now required to ensure both quality and stability of protein therapeutics. Micro-Flow Imaging is ideal for particle characterization because it uses dynamic imaging for direct particle detection. This technology enables rapid quantification of particle size and shape for tens of thousands of particles per sample and the sensitivity to detect translucent protein particles. As a result, MFI analysis provides the ability to rapidly classify protein aggregates and other particle types such as silicone oil and extrinsic contaminants. In this webinar, Daniel Weinbuch will present how to use filter analysis on MFI to accurately classify particles, such as silicone oil and protein, based on shape and image intensity.

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Current Industry Perspectives on Monitoring of Protein Aggregation in Biopharmaceuticals

April 9, 2014
Lillian Li, Associate Scientist in Formulation Stability Platform, Sanofi Pasteur
Mario Hubert, Ph.D., Principal Scientist, Bristol Myers Squibb
Zahir Akhunzada, Ph. D., Research Scientist, PPD, Analytical & Bioanalytical, Bristol-Myers Squibb
Amber Fradkin, Ph.D., Scientist, Amgen

Join us for a panel discussion on current approaches used to detect and monitor protein aggregates using MFI throughout the product development and commercialization process for therapeutic proteins and peptides. During the discussion, industry experts will review analytical methods and discuss how data on protein aggregation is being used in regulatory submissions of biopharmaceuticals.

Topics include:

  • Use of MFI imaging-based technology for characterization of sub-visible particles, and sensitive detection of protein aggregates at >2 microns
  • Monitoring biopharmaceutical quality and safety using sub-visible particle analysis with MFI
  • Immunogenicity concerns relating to protein aggregates
  • Control strategy for protein aggregation using MFI in biopharmaceuticals and vaccines

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Go with the flow: Easy particle characterization with Micro-Flow Imaging

February 27, 2014
Jessica Dermody, Ph.D., Field Application Scientist, ProteinSimple
Chris Heger, Ph.D., Field Application Scientist, ProteinSimple

Characterization of protein aggregates and other sub-visible particles is essential for monitoring changes in product quality and safety throughout biopharmaceutical development. A unique challenge for particle characterization is the simultaneous presence of protein aggregates and other particle types such as silicone oil micro-droplets, air bubbles, and extrinsic contaminants protein formulations. Traditional techniques providing only size and concentration information cannot distinguish these groups from each other. More comprehensive technologies must therefore be utilized to detect and classify particles into sub-groups based on their unique morphology and particle characteristics.

ProteinSimple's Micro-Flow Imaging (MFI) is ideal for characterization of biopharmaceuticals because it not only measures particle size and count, but also provides quantitative images that allow scientists to sensitively discriminate particle types based on their shape characteristics. In this webinar we will demonstrate how image information provided by MFI can be used to quickly and easily design morphologic filters for routine analysis. We will also review a variety of case studies which describe how to customize and test these filters for accurate particle classification in protein formulations.

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Image is Everything: Sub-visible Particle Analysis of BioPharmaceuticals

November 26, 2013
Angelica Olcott, Ph.D., MFI Product Manager, ProteinSimple

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Automation of Particle Characterization Using Micro-Flow Imaging

September 18, 2013
Dan Bach Kristensen, Ph.D., Senior Pharmaceutical Chemist, Tekeda Denmark
Angelica Olcott, Ph.D., MFI Product Manager, ProteinSimple

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Implementation of Micro-Flow Imaging (MFI) in QC Environments using IQ/OQ and 21 CFR Part 11

March 14, 2013
Craig Haupt, Director of Customer Care, ProteinSimple
Angelica Olcott, Ph.D., MFI Product Manager, ProteinSimple

Robust instrument validation in an industrial or biotechnology setting can often be complex and time-consuming to create on its own. To aid in this process, ProteinSimple offers 21 CFR Part 11-enabling software with our instrumentation (MFI View System Software), as well as instrument qualification services. IQOQ (Instrument Qualification/Operational Qualification) confirms instrument performance according to manufacturing specifications, and can be implemented following system installation. IQOQ in a QC environment provides a number of benefits for verification of instrument accuracy and proper maintenance, and can form a part of a customer's overall system validation. In this tech talk, Craig Haupt, our Director of Field Service Engineering, describes the format of IQOQ for MFI systems and describes specific examples of MVSS software designed for 21 CFR Part 11. Industry experts are invited to join the Q&A session which follows and provide their perspective.

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Practical Considerations for the Implementation of Subvisible Particle Characterization in Biotherapeutic Research and Development

November 15, 2012
Robert Simler, Ph.D., Senior Scientist, Genzyme – A Sanofi Company

Subvisible particle formation has become a key attribute that needs to be measured, monitored and characterized during the development of a protein biotherapeutic. As subvisible particle detection is still a relatively recent addition to the analytical toolbox, it is being deployed into many areas of research and development simultaneously, each with their own obstacles and challenges. This talk will focus on the advantages and practical considerations that must be accounted for when implementing subvisible particle detection, specifically using the ProteinSimple Micro-Flow Imaging (MFI) system, into biotherapeutic development. Topics covered will include employing the MFI to gain a better mechanistic understanding of subvisible particle formation, advanced data analysis to obtain quantitative measurements other than particle concentrations to assess product quality, implementing subvisible particle monitoring during formulation screening studies and assessing the risk posed by subvisible particles as a function of the route of administration.

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