The programme is aimed at those working in research and clinical trials, as well as anyone interested in monoclonal antibody development and project planning. 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.
Objectives
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.
Background
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.
Programme
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
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, Development, and Application
The anatomy of ADCs: linkers, drugs and antibodies
Clinical applications of ADCs: successes and lessons learned
Formulation and analytics for ADCs
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 also have the opportunity to learn and discuss topics such as the selection of the right linker, payload and conjugation method and much more.
Accommodation CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG when you have registered for the conference. Reservation should be made directly with the hotel. Early reservation is recommended.
Social Event On the evening of the first course day, the participants are cordially invited to a dinner. This event is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
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 and includes dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable.
Presentations/Certificate 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.
Conference language The official conference language will be English.
Testimonials
