Advanced Therapy Medicinal Products (ATMP)

Cell therapies, gene therapies and tissue-engineered products require Grade A environments with containment requirements that exceed conventional pharmaceutical manufacturing. The intersection of sterility assurance, biological containment and operator protection makes ATMP facility design one of the most complex engineering challenges in the sector. We design for autologous and allogeneic production models, with complete inter-campaign segregation strategies.

Regulatory framework: EU GMP Part IV (ATMP-specific guidelines), EMA Committee for Advanced Therapies (CAT) review, FDA CBER and 21 CFR Part 1271 for US-market programmes. A genuine positioning advantage for manufacturers establishing production capacity in Europe.