Target Group
- Quality Control
- Quality Assurance
- Regulatory Affairs
- Research and Development
Objectives
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.
Background
Programme
- 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
- Development of novel analytical methods (needs and challenges)
- Validation of analytical methods (LOQ)
- 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
- 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
- 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 its 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 | Dr Markus Fido
- Spectroscopic Analysis and Chromatography | Dr Dietmar Reusch & Dr Michael Leiss & Henno van den Hooven
- Cellular Assays | Markus Roucka & Dr Ulrike Herbrand
- Relevant Physico-chemical Methods – like CD, fluorescence, IR spectroscopy, AUC, SEC-MALLS, DLS, DSC, microflow imaging, etc. and biophysical methods
Further Information
Technical Requirements
We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate plus VAT)
ECA Members € 1,890
APIC Members € 1,990
Non-ECA Members € 2,090
EU GMP Inspectorates € 1,045
The conference fee is payable in advance after receipt of invoice.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Contacts:
Questions regarding content:
Mr Axel H. Schroeder (Operations Director), +49(0)62 21 84 44 10, schroeder@concept-heidelberg.de
Questions regarding organisation:
Ms Sonja Nemec (Organisation Manager) +49(0)62 21 84 44 24, nemec@concept-heidelberg.de.
Date & Time
Wed, 04 February 2026, 08:30 – 17:00 h
This training/webinar cannot be booked. Send us your inquiry by using the following contact form.
To find alternative dates for this training/webinar or similar events please see the complete list of all events.
For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.
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This course is part of the GMP Certification Programme "ECA Certified Biotech Manager"
Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
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