Markus Roucka
VelaLabs
Referent:innen
Zielsetzung
At the end of this course, participants will have a comprehensive understanding of monoclonal antibodies (mAbs). From the early development process, through upstream and downstream manufacturing, to different analytical approaches, clinical trials and stability studies. The course is designed to ensure that participants not only understand the theoretical underpinnings of mAb development, but also the practical and regulatory challenges that must be overcome to bring a therapeutic antibody from the laboratory to the clinic and ultimately to the market.
Hintergrund
Monoclonal antibodies (mAbs) are increasingly becoming a cornerstone of therapeutic strategies in a wide range of diseases, including oncology, rheumatology and infectious diseases. Their ability to target specific antigens with high precision makes them critical tools in the fight against complex diseases. The global market for monoclonal antibodies is expanding not only because of their efficacy but also because of technological advances in genetic engineering and bioprocessing.
The development of monoclonal antibodies involves a sophisticated and multidisciplinary approach that integrates the fields of molecular biology, genetic engineering, immunology and pharmacology. The complexity of the development process is compounded by the stringent requirements imposed by regulatory authorities to ensure the safety, efficacy and quality of these biopharmaceuticals before they reach the market.
Guidelines from regulatory agencies such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) provide structured pathways and requirements for the development and approval of monoclonal antibodies. These guidelines include detailed criteria for the manufacturing process, preclinical and clinical testing and submission of regulatory dossiers.
Given the rigorous and detailed nature of these guidelines, professionals involved in mAb development must have a deep understanding of both the scientific and regulatory landscape. It is essential that these professionals are familiar with critical guidelines such as ICH Q6B, which details test procedures and acceptance criteria for biotechnology and biological products, or ICH Q8(R2), which provides guidance on pharmaceutical development.
The development of monoclonal antibodies involves a sophisticated and multidisciplinary approach that integrates the fields of molecular biology, genetic engineering, immunology and pharmacology. The complexity of the development process is compounded by the stringent requirements imposed by regulatory authorities to ensure the safety, efficacy and quality of these biopharmaceuticals before they reach the market.
Guidelines from regulatory agencies such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) provide structured pathways and requirements for the development and approval of monoclonal antibodies. These guidelines include detailed criteria for the manufacturing process, preclinical and clinical testing and submission of regulatory dossiers.
Given the rigorous and detailed nature of these guidelines, professionals involved in mAb development must have a deep understanding of both the scientific and regulatory landscape. It is essential that these professionals are familiar with critical guidelines such as ICH Q6B, which details test procedures and acceptance criteria for biotechnology and biological products, or ICH Q8(R2), which provides guidance on pharmaceutical development.
Zielgruppe
The programme is aimed at those working in research, clinical trials and anyone interested in developing monoclonal antibodies. By targeting this wide range of professionals, the training aims to create a knowledgeable and skilled workforce capable of advancing the field of monoclonal antibodies from the research phase through to clinical use and successful market entry.
Date / Venue / Presentations / Certificate
Date
Tuesday, 20 May 2025, 09.00 h – 16.30 h
(Registration and Coffee 08.30 h – 09.00 h)
Wednesday, 21 May 2025, 09.00 h – 15.30 h
Venue
Doubletree by Hilton Vienna Schönbrunn
Schlossallee 8
1140 Vienna, Austria
Phone +43/1/89110
Email info@doubletree-schonbrunn.at
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.
After the event, you will automatically receive your certificate of participation.
Programm
Gesamtes Programm als PDF herunterladen
World of mAbs: Introduction and Overview – From Idea to Product
- What are monoclonal antibodies (mAbs)?
- Conception to market – developing effective mAbs
- Areas of application: therapeutic applications, diagnostics, research
Analytical Concept for Fc and Fab
- Antibody structures: Fc and Fab analysis
- Ligand Binding Assay (LBA) and other techniques
- Bioassay validation
Production Processes of mAbs: From Upstream to Downstream
- Regulatory aspects
- Techniques and technologies
- Challenges and solutions in scale-up
- Case studies
Production processes of mAbs: Choosing the right Expression System
- Exploring platforms for mAbs production
- Weighing the pros and cons: strategies for monoclonal antibody production
- Optimizing outcomes: evaluating hosts for efficiency and quality
Purification Methods: Antigen Affinity Purification (Downstream)
- Principles of antigen-affinity purification: selectivity and specificity
- Technological advances in affinity media and ligand design
- Integration into downstream processing: purity, yield and scalability
- Optimization of purification processes for mAbs
Liquid Chromatography Mass Spectrometry (LCMS)
- LC-MS in mAbs characterization: sensitivity, specificity and throughput
- Comparative analysis: when to use LBA vs. LC-MS
- Glycosylation and its effect
Lyophilization of Monoclonal Antibodies
- Basic information on lyophilization – why answd how?
- Challenges and opportunities of lyophilization of mAbs
- Development of lyophilized formulations and required analytical methods
- Lyophilization process development, including QbD and lyomodelling
Clinical Development Plan
- Blueprint for success: mapping the clinical trial journey
- Critical strategies for effective clinical development
- Navigating clinical development stages – Phase I - III
Formulation strategies and stability testing for mAbs
- Developability assessment and early formulation screenings
- Phase appropriate formulation strategies for mAbs
- Conducting stability studies: protocols, parameters and analytical methods
ADC (Antibody Drug Conjugates) - Design and Application
- The anatomy of ADCs: linkers, drugs and antibodies
- Clinical applications of ADCs: successes and lessons learned
- Future directions: innovations in linker chemistry and targeted delivery
Bi- and tri-specific Conjugates - Potential and Challenges
- Designing bi- and tri-specific antibodies: concepts and constructs
- Therapeutic potential: targeting complex diseases with multifunctional antibodies
- Overcoming development challenges: manufacturing, stability and efficacy
Interactive Workshop about the Key Components in the Development of ADCs
This workshop provides a comprehensive introduction to the critical parameters that influence the efficacy and safety of ADCs.
Participants will learn more about the following subjects:
- How to choose the right target antigen to maximise selectivity?
- Which properties of the antibody are crucial for optimal binding and stability?
In this workshop participants have also the opportunity to learn and discuss topics such as the selection of the right linker, payload and conjugation method and much more.
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This course is part of the GMP Certification Programme "ECA Certified Biotech Manager"
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E-Mail: info@concept-heidelberg.de
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