Protein Analytics Evaluation, Implementation and Use of Suitable Technologies

Protein Analytics

Neuss, Germany

Course No 20750

This course is part of the GMP Certification Programme "ECA Certified Biotech Manager". Learn more.

 

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Speakers

Dr Markus Fido, MFi Bio-Consulting, Austria
Dr Ulrike Herbrand, Charles River Laboratories, Germany
Dr Wolf Hagen Holtkamp, Paul-Ehrlich Institut, German Federal Agency for Vaccines and Biomedicines
Dr Henno van den Hooven, MSD, The Netherlands
Dr Michael Leiss, Roche Diagnostics, Germany
Dr Dietmar Reusch, Roche Diagnostics, Germany
Markus Roucka, Vela Labs, Austria

Objectives

Biopharmaceutical processes and the specifics in the control of these processes are highly complex. Compared to the “classic” chemical pharmaceutical products and processes, they are frequently on a much higher level – as, for instance, in the case of proteins. In addition, the drug product alone possibly poses real challenges due to the restraints created by the nature of the protein.

Over the last years a huge variety of analytical methods – ranging from physicochemical tests to biological assays – have been established.
As the range of biopharmaceuticals is evolving, new tests have to be developed, validated, transferred, applied at the same time. And, last but not least, they have to be accepted by regulatory authorities.

In this course, pros and cons of established and newly emerging assays will be discussed. Industry experts will share their in-depth knowledge and experiences. During workshops in small groups, you will deepen your knowledge about special methods and their validation issues. The course has been designed to answer your individual questions concerning assays for the quality control of proteins. In addition, you will benefit from information on bioassays and current hot topics like host cell proteins. Therefore, the number of participants is strictly limited. We recommend early registration.

Background

The number of biopharmaceutical products is increasing, in clinical phases as well as in the market. Due to their high complexity they show an excellent targeting ability. To ensure the quality and targeting ability, a profound analysis of the drug substance’s quality is of utmost importance. This particularly applies to protein-based products and in the production of recombinant proteins.

However, it cannot be measured by analytical tests alone. Therefore, the development process of all biopharmaceutical products requires non-analytical tests to fully evaluate their functionality and safety. Biopharmaceutical development is thus a multi-disciplinary effort involving many professionals with diverse backgrounds. In addition, the relevant guidelines for analytical methods are also subject to repeated updates in order to follow the state of the art in science and technology (ICH Q2 (R2), ICH Q14, ICH Q6b and more).

Target Group

This course is of interest to those who are involved in
  •  Quality Control
  •  Quality Assurance
  •  Regulatory Affairs
  •  Research and Development
of proteins, processes and analytical assays in the biopharmaceutical industry.

Presentations / Certificate

The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.

Programme

Why Do We Test? What Must be Analysed?
  • ICH guideline Q6B
  • Composition of product (desired product, excipients, impurities, contaminants)
  • Application of tests
Regulatory Aspects on Analytical Methods
  • What do we expect from bioanalytical methods?
  • Biopharmaceuticals - challenges for analytical Methods
  • Development of novel analytical methods (needs and challenges)
  • Validation of analytical methods (LOQ)
Liquid Chromatography
  • Reversed-phase high-performance liquid chromatography
  • Size-exclusion chromatography
  • Ion-exchange chromatography
  • Applications for biopharmaceuticals
Controlling Host-Cell Impurities in Biopharmaceuticals
  • Why HCP analytics?
  • Means to analyze HCP and limitations of applied methods
  • Control strategy and regulatory expectations
ELISA, ECL Technologies
  • ECL introduction using MesoScaleDiscovery device
  • ELISA based setups for PK & immunogenicity
  • ECL – optimizing immunogenicity assays
  • Validation of PK and ADA screening assay
Mass Spectrometry
  • Intact Mass Analysis - investigation of antibody heterogeneity
  • LC/MS - investigation of primary structure and modifications
  • Fundamentals of MALDI-MS
    MALDI-MS as a complementary technique to ESI-MS
Characterization of Biotherapeutic Proteins by Size-exclusion Chromatography Coupled to Native Mass Spectrometry
  • Status quo: Methods for therapeutic Protein characterization
  • Current questions and challenges
  • Innovative approaches and methods
  • Application and examples
Bioassays
  • Types of assays for different molecules
  • Mechanism of Action (MoA) reflecting assays
  • Surrogate Approaches for tedious primary assays
  • Biosimilarity assessment
Non-Cellular Assays (SPR, Lectin Binding)
  • Orthogonal methods to Bioassays
  • Prediction of potency with non-cellular assays (surrogate assays)
  • Characterization of antibodies and its biosimilars
  • Explanation of Surface Plasmon Resonance (SPR) technology and lectin array
Glycoanalysis
  • Glycosylation of Protein
  • Why glycoanalysis?
  • Principles of glycoanalysis
  • Separation based Methods
  • MS based methods
  • Comparison of methods for glycoanalysis
Parallel Interactive Workshop Sessions with Case Studies and Practical Examples:
  • Immunochemical Methods - Dr Markus Fido
  • Spectroscopic Analysis and Chromatography - Dr Dietmar Reusch, Dr Michael Leiss, Henno van den Hooven
  • Cellular Assays - Markus Roucka, Dr Ulrike Herbrand
You will be able to attend two of the parallel sessions. Please make your choice when you register for the Course
 
Additional Methods for Protein Characterization
  • Relevant Physico-chemical Methods – like CD, fluorescence, IR spectroscopy, AUC, SEC-MALLS, DLS, DSC, microflow imaging, etc.

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