Monoclonal Antibodies - From Concept to Approval - Live Online Training

22/23 October 2024

Course No. 21299



Dr. Andreas Nechansky

Dr. Andreas Nechansky


Markus Roucka

Markus Roucka


Markus Haberger

Markus Haberger

Roche Diagnostics

All times mentioned are CET.


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.


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.

Target Group

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.

Technical Requirements

We use WebEx for our live online training courses and webinars. At you will find all the information you need to participate in our trainings 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.

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.


Monoclonal Antibodies - From Concept to Approval - Live Online Training

Seminar Programme as PDF

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
  • Techniques and Technologies
  • Optimizing expression: techniques for enhancing yield and quality
  • Challenges and solutions in scale-up for commercial production
Production Processes of mAbs: Bacterial vs Mammalian Cell Production
  • Choosing the right system: bacterial vs. mammalian cell lines
  • Pros and cons: production strategies for monoclonal antibodies
  • Evaluating hosts for optimal antibody yield
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
Clinical Program – 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 and Stability Studies
  • Formulation strategies for mAbs: enhancing stability and Bioavailability
  • Conducting stability studies: protocols, parameters and predictive model
  • Implementation and importance of stability studies
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


This course is part of the GMP Certification Programme "ECA Certified Biotech Manager" Learn more

ECA-Member*: € 1690,-
Non ECA Member*: € 1890,-
EU/GMP Inspectorates*: € 945,-
APIC Member Discount*: € 1790,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
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Please contact us:
Tel.: +49 6221 8444-0

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