All times mentioned are CEST.
Zielsetzung
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
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
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 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.
Programm
Gesamtes Programm als PDF herunterladen
- 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
- Techniques and Technologies
- Optimizing expression: techniques for enhancing yield and quality
- Challenges and solutions in scale-up for commercial production
- Bacterial vs. Mammalian Cell Lines
- Pros and cons: production strategies for monoclonal antibodies
- Evaluating hosts for optimal antibody yield
- 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
- 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
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This course is part of the GMP Certification Programme "ECA Certified Biotech Manager"
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Seminarprogramm als PDF
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