Biotechnology & R&D

Biotechnology facilities must evolve at the pace of the science. A cleanroom built for Phase I must support commercial manufacturing without reconstruction. We design environments that scale: modular GMP suites for early validation, classified production spaces for commercial scale, BSL-1 to BSL-3 containment for programmes with biological agents. Cell culture, fermentation, genomics, protein production — the environmental specification follows the science.

Regulatory alignment integrated from the first layout drawing: ISO 14644, GMP Annex 1, EMA guidelines for biologics, FDA 21 CFR 600 series, GMP Part IV and FDA 21 CFR Part 1271 for ATMP programmes. Integration of cryogenic biobanks for programmes requiring long-term preservation of biological material.