Biotechnology and R&D

Biotechnology facilities must evolve at the pace of the science. A cleanroom built for Phase I must support commercial manufacturing without rebuilding. 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 involving biological agents. Cell culture, fermentation, genomics, protein production — the environmental specification follows the science.

Regulatory alignment built in from the first layout drawing: ISO 14644, GMP Annex 1, EMA guidelines for biologicals, FDA 21 CFR series 600, GMP Part IV and FDA 21 CFR Part 1271 for ATMP programmes. Cryogenic biobank integration for programmes requiring long-term preservation of biological material.