Designing effective contamination prevention strategy: Crucial factors to consider for cell therapy production

In advanced therapy medicinal products (ATMP) manufacturing, the quality and safety of the product needs to be ensured from the first stages of development. Discover how to design an effective contamination prevention strategy that will minimize risks to cell therapy products and allow you to implement appropriate control measures.

The webinar will outline the types and sources of particulates in a cell therapy production environment and their impact on product quality and safety. It will also explore the role of laboratory equipment in contamination prevention, and provide clarity around regulatory requirements, validation methodology, and the validation process for laboratory equipment.

Key learning objectives

• GMP guidance for ATMP – how to identify risks to cell therapy products and implement appropriate control measures
• The role of laboratory equipment in contamination prevention and what to look for when sourcing suitable equipment
• Types and sources of particulates in the cell therapy production environment and their impact on product quality and safety
• Regulatory requirements and validation methodology for particle emission testing
• The validation process and compatibility of lab equipment with disinfection protocols
• How to evaluate effectiveness of lab equipment, including built-in features designed to control contamination
• How to determine lab equipment suitability for GMP cleanroom environments

Who should attend?

Lab scientists, lead scientists, R&D scientists, principal investigators, engineers and lab or facility managers involved in the cell therapy development journey starting from R&D and pre-clinical / clinical testing (translational institutes, medical institutes, academic incubators, GMP production facilities) through to the later stages of cell therapy development, such as commercialisation / scale up and QC testing, usually taking place in Biotech, Biopharma, Contract Research Organisations (CRO), Contract Manufacturing Organisations (CMO) & Contract Development and Manufacturing Organizations (CDMO).

This webinar will be of interest to principal investigators, lead scientists, research scientists, lab managers, facility managers, process engineers, and others working in this field.

Certificate of attendance

All webinar participants can request a certificate of attendance, including a learning outcomes summary, for continuing education purposes.