In the rapidly evolving world of pharmaceuticals, advancements in science and technology are continually reshaping the landscape of healthcare. One of the hottest topics of the last year is Advanced therapy medicinal products (ATMPs), more specifically Cell & Gene Therapy Products. These medicines for human use are based on cells, tissues, and genes. The number of cell & gene products has increased rapidly in recent years. Many Pharma companies and businesses are faced with new challenges in their development and production.
Expert-Led Trainings from Industry Leaders
We have been organizing several trainings tackling these issues to help you stay ahead in the dynamic Pharma industry.
The pathways to meeting CMC requirements are not as clearly defined. Novel approaches must be taken to ensure the product’s identity, strength, quality, purity, or potency. The Cell & Gene Therapy Products – CMC & Quality Requirements training provides a practical & in-depth understanding of CMC & quality requirements and brings clarifications on global regulation, requirements, compliance & quality concerns.
Cutting-Edge Topics Covered:
- The ATMP regulatory framework
- Quality raw materials & starting materials criteria
- Process development & manufacturing strategy
- Process validation requirements
- Method validation/qualification strategies
- Release specifications for ATMPs
- Analytical characterization & comparability
- Data requirements for manufacture and control
- Gene therapy product class specificities
- Manufacturing process changes/ Change control
Enrich your expertise and empower your career by joining us on 19 – 21 September 2023 in Vienna, Austria. This training is also available as an Online Live Stream | 9:00 CEST – 15:00 CEST.
If your business needs to gain a comprehensive overview of the stability and shelf-life regulatory landscape and in-depth insights into cell and gene therapy products, the Stability & Shelf Life of Cell & Gene Therapy Products training is the right fit for you.
Practical Knowledge and Hands-On Experience:
- Guidance and regulation for the stability of cell and gene therapies/ ATMPs
- Limitations of accelerated and stress stability assessment
- Instabilities by chemical, physical, and microbiological factors
- Analytical methodology for stability assessment
- The role of excipients in the stability of ATMPs
- Transport and shipping impact on stability and shelf-life
- Importance of in-use stability studies
With the increasing complexity of today’s therapeutics like Biologics, Biopharmaceuticals, Biosimilars & ATMPs, unique issues have emerged especially in managing immunogenicity in clinical practice and during drug development. The Immunogenicity of Biologics, Biopharmaceuticals & ATMPs course brings a practical & in-depth understanding of immunogenicity in pre-clinical and clinical development and brings clarifications on regulation, requirements, and quality concerns.
Expert-Led Training from Industry Leaders:
- Guidelines, regulatory & quality requirements for immunogenicity
- Immerging into the field of immunology & immune reactions
- Different factors which may impact immunogenicity
- Analytical development – screening, confirmation & neutralization assays
- Characterization and monitoring of ADAs with appropriate analytical tools
- Study design & bioanalytical methods as characterization tools
- Immunogenicity risk assessment, mitigation & risk minimization
- Clinical development – pitfalls & challenges, strategies to avoid ADA formation
- Clinical synopsis with special emphasis on immunogenicity
- Case studies on mAbs, ATMPs & Biosimilars
Let’s unleash the full potential of cell and gene therapies and create a world where diseases are no longer insurmountable barriers to human well-being. We will be happy to meet you at one of our trainings.