Advanced Therapy Medicinal Products (ATMP)

Cell therapies, gene therapies and tissue-engineered products demand Grade A environments with containment requirements that exceed those of 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 segregation strategies between manufacturing campaigns.

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