Objectives
Background
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.
Target Group
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
After the event, you will automatically receive your certificate of participation.
Programme

Seminar Programme as PDF
- What are monoclonal antibodies (mAbs)?
- Conception to market – developing effective mAbs
- Areas of application: therapeutic applications, diagnostics, research
- Antibody structures: Fc and Fab analysis
- Ligand Binding Assay (LBA) and other techniques
- Bioassay validation
- Regulatory aspects
- Techniques and technologies
- Challenges and solutions in scale-up
- Case studies
- Exploring platforms for mAbs production
- Weighing the pros and cons: strategies for monoclonal antibody production
- Optimizing outcomes: evaluating hosts for efficiency and quality
- 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
- LC-MS in mAbs characterization: sensitivity, specificity and throughput
- Comparative analysis: when to use LBA vs. LC-MS
- Glycosylation and its effect
- 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
- Blueprint for success: mapping the clinical trial journey
- Critical strategies for effective clinical development
- Navigating clinical development stages – Phase I - III
- Developability assessment and early formulation screenings
- Phase appropriate formulation strategies for mAbs
- Conducting stability studies: protocols, parameters and analytical methods
- 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
- Designing bi- and tri-specific antibodies: concepts and constructs
- Therapeutic potential: targeting complex diseases with multifunctional antibodies
- Overcoming development challenges: manufacturing, stability and efficacy
- How to choose the right target antigen to maximise selectivity?
- Which properties of the antibody are crucial for optimal binding and stability?
This course is part of the GMP Certification Programme "ECA Certified Biotech Manager" Learn more
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.
not available
not available
Not available
Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

- Our Service
Testimonials
Your Certificate
Seminar Programme as PDF