Protein Analytics With laboratory visit at Vela Lab
Speakers
Rainer Fedra
Vela Labs
Dr Markus Fido
Vela Labs
Dr Ulrike Herbrand
Charles River Laboratories
Klaus Hajszan
Vela Labs
Dr Silke Huber
BSL Bioservices
Henno van den Hooven
MSD
Iris Koller
Vela Labs
Dr Michael Leiss
Roche, Diagnostics
Dietmar Reusch
Roche Diagnostics
Markus Roucka
Vela Labs
Dr. Olaf Stamm
Charles River Laboratories
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 methodss, 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
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 bio-pharmaceutical industry.
Site Visit at Vela labs
VelaLabs is a world-wide acting, GMP-certified contract laboratory that offers in-depth analytical characterisation services for proteins (Biopharmaceuticals, Biologics and Biosimilars).
Combining a focused, customer - orientated approach, a highly motivated team and a broad expertise in analytical development and quality control, VelaLabs is dedicated to support the customer’s needs from research activities to clinical phases and up to product commercialization.
Programme
Why do we test? What must be analysed?
ICH guideline Q6B
Composition of product (desired product, excipients, impurities, contaminants)
Application of tests
Validation of Protein Analytical Technologies
Definitions of validation parameters
Method validation as a lifecycle approach:
- actual validation
- transfers
- maintenance
Analytical Methods for the Analysis of Excipients in formulations of Monoclonal Antibodies
Status quo: methods for Release
Current Questions and Challenges
Innovative Approaches and Methods
Application and Examples
Liquid Chromatography
Reversed-phase high-performance liquid chromatography
Size-exclusion chromatography
Ion-exchange chromatography
Applications for biopharmaceuticals
Spectroscopic Analysis
Application of UV spectroscopy for concentration measurements
Application of UV and fluorescence spectroscopy for structural studies
Industry examples
ELISA, ECL-Technologies
ELISA setups for immunogenicity
ECL introduction and ELISA comparison
ECL – optimizing immunogenicity assays
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
The devil in the detail – HCP assay performance by design Considerations for the choice of a suitable antigen including regulatory and practical requirements
Optimization of the immunization process by cascade/subtractive approaches
Qualification of antigen and antisera as reagents for a GMP compliant assay development
Targeted enhancement of coverage by combining tools from proteomics, protein synthesis and immunization
Non-Cellular assays (Biacore, Receptor-binding)
Characterization of antibodies with non-cellular assays
Explanation of Surface Plasmon Resonance (SPR) technology and alternatives
Cost-effective procedures while maintaining and increasing the accuracy and sensitivity
Guidelines for ligand binding assays
GLP Validation of Immunoassays for GLP Bioanalytics
Ligand binding assay: ELISA formats and detection mechanisms
Development and optimization: Setting acceptance criteria
Relevant guidelines
Validation procedure
Curve fitting and relative potency
Curve fitting
Regression models (linear, 4-PL, 5-PL)
Relative potency evaluation
Bioassays
Characterization of antibodies with non-cellular assays
Explanation of Surface Plasmon Resonance (SPR) technology and alternatives
Cost-effective procedures while maintaining and increasing the accuracy and sensitivity
Guidelines for ligand binding assays
Physicochemical Methods
Relevant physico-chemical Methods – like CD, fluorescence, IR spectroscopy, AUC, SEC-MALLS, DLS, DSC, microflow imaging, etc.
Compendial release tests like appearance, clarity, colour, pH, extractable volume, content uniformity, particulate matter by laser obscuration spectroscopy, osmolality
Glycoanalysis
Glycosylation of protein
Why glycoanalysis?
Principles of glycoanalysis
Separation based methods
MS based methods
Comparison of methods for glycoanalysis
Workshop Sessions :
Immunochemical Methods
Spectroscopic Analysis
Chromatography
Cellular Assays
This course is part of the GMP Certification Programme "ECA Certified Biotech Manager" Learn more
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Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
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