Manufacturing Environment Decontamination for Cell and Gene Therapies: What FDA's 2026 CMC Flexibility Means for VHP

FDA's January 2026 CMC flexibility guidance accelerates cell and gene therapy commercialization. MHRA's decentralized manufacturing framework expands the production footprint. Both developments concentrate advanced therapy manufacturing in environments where contamination is an existential process risk — and where VHP is the only Category A-recognized low-temperature decontamination option.