Live Online Training: Protein Analytics

Live Online Training: Protein Analytics

Course No 18653

All times mentioned are CEST.

Costs

ECA-Member: EUR 1690,--
Non ECA Member: EUR 1890,--
EU/GMP Inspectorates: EUR 945,--
APIC Member Discount: EUR 1790,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

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. VelaLabs, 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 Live Online Training, 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.

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.

Target Group

This Live Online Training 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.

Technical Requirements

For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in.  Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

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
Interactive Session 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
Additional Methods for Protein Characterization
  •  Relevant Physico-chemical Methods – like CD, fluorescence, IR spectroscopy, AUC, SEC-MALLS, DLS, DSC, microflow imaging, etc. and biophysical methods

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