Dr Markus Fido, Vela Labs, Austria
Dr Ulrike Herbrand, Charles River Laboratories, Germany
Dr Henno van den Hooven, The Netherlands
Dr Michael Leiss, Roche Diagnostics, Germany
Dr Manuela Leitner, Austrian Agency for Health and Food Safety (AGES)
Dr Dietmar Reusch, Roche Diagnostics, Germany
Markus Roucka, Vela Labs, Austria
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.
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.
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.
Why do we test? What must be analysed?
Regulatory Aspects on Analytical Methods
- ICH guideline Q6B
- Composition of product (desired product, excipients, impurities, contaminants)
- Application of tests
- What do we expect from bioanalytical methods?
- Biopharmaceuticals - challenges for analytical methods
- Analysis during product life cycle
- Applications – In-/On-/At-/Off-line analysis
Controlling Host-Cell Impurities in Biopharmaceuticals
- Reversed-phase high-performance liquid chromatography
- Size-exclusion chromatography
- Ion-exchange chromatography
- Applications for biopharmaceuticals
- Why HCP analytics?
- Means to analyze HCP and Limitations of applied methods
- Control strategy and regulatory expectations
- ECL introduction using MesoScaleDiscovery device
- ELISA based setups for PK & immunogenicity
- ECL – optimizing immunogenicity assays
- Validation of PK and ADA screening assay
Characterization of biotherapeutic proteins by size-exclusion chromatography coupled to native 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
- Status quo: Methods for therapeutic Protein Characterization
- Current Questions and Challenges
- Innovative Approaches and Methods
- Application and Examples
Non-Cellular assays (SPR, Lectin binding)
- Types of Assays for different molecules
- Mechanism of Action (MoA) reflecting assays
- Surrogate Approaches for tedious primary assays
- Biosimilarity assessment
- Orthogonal methods to Bioassays
- Prediction of potency with non-cellular assays (surrogate assays)
- Characterization of antibodies and their biosimilars
- Explanation of Surface Plasmon Resonance (SPR) technology and lectin array
- Glycosylation of protein
- Why glycoanalysis?
- Principles of glycoanalysis
- Separation based methods
- Ms based methods
- Comparison of methods for glycoanalysis
- Immunochemical Methods
- Spectroscopic Analysis
- Cellular Assays
- 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, osmolarity