October 2025
Advancing Quality Systems for Cell and Gene Therapy
The increasing maturity of cell and gene therapy programmes is driving greater focus on robust quality systems and phase-appropriate analytical strategies.
Recent developments in the UK and European advanced therapy landscape highlight the importance of reliable analytical methods, appropriate validation strategies and strong documentation throughout product development.
i-CELLBIO supports clients in translating scientific and regulatory expectations into practical quality systems and laboratory procedures.
The British Pharmacopoeia/MHRA has developed dedicated ATMP guidance covering areas including flow cytometry, genomic titre, vector copy number and T-cell/NK-cell characterisation