Aseptic processing applied in Gene & Cell therapy following QRM principles
Aseptic processing principles following a Quality Risk Management (QRM) approach that includes Quality by Design (QbD). Resolving the conflicts of EU GMP Annex 1 and GMP for ATMPs.
Applying the ATMP manufacturing platform attributes of: Flexibility/ adaptability, digitalization, modularity, scalability and intensification together with GMP compliance in a viral vector formulation and filling process including vial and bag container formats.
Characterization of protective airflow and ‘First air’ protection in bioburden control and aseptic processing steps considering how protective airflow product products, what puts protection at risk and how to manage the limitations of environmental and process monitoring (Annex1 GMP requirement).