Bioprocessing 4.0: Endotoxin Control for Cell & Gene Therapies

The Regulatory Cliff
FDA now mandates ≤0.001 EU/mL endotoxins in advanced therapies - traditional filters permit breakthrough.

Precision Filtration Breakthrough
Pharma-grade solutions deliver:
🧪 Asymmetric ceramic membranes enabling 200L/m²/hr flux at 0.02μm
🧪 In-situ SIP/CIP validation per ASTM F838-15a
🧪 Extractables database covering 1,200 compounds

Compliance Impact
Top 10 Biologics Manufacturer:

• 99.3% reduction in lot rejections

• QC validation time cut from 120 to 8 hours

• $2.7M annual QC savings

Resource: [Get ATMP Compliance Kit]