alpha, alpha-Trehalose, Dihydrate, Low Endotoxin, NF, EP, JP, ChP bioCERTIFIED (TM)
100% Tested.100% Transparent. 100% Tested.

Spectrum Chemical bioCERTIFIED™ products are uniquely suited for bioprocessing by biopharmaceutical manufacturers. From drug discovery to pilot and scale-up to production, bioCERTIFIED™ products help simplify and standardize bioprocessing by ensuring consistent raw material quality. All bioCERTIFIED™ materials and finished goods are subject to in-house laboratory testing and analysis in cGMP-compliant facilities. This includes expanded testing for bioburden, endotoxin and elemental impurities.

• Extensive product breadth and packaging flexibility for upstream and downstream bioprocessing
• Expanded laboratory testing, certifications and documentation including additional lot testing for bioburden, endotoxins and elemental impurities
• Comprehensive regulatory and scientific documentation to help meet global quality, regulatory and compliance requirements
• Manufactured, packaged and stored under current Good Manufacturing Practices (cGMP) per 21CFR part 211 in FDA-registered and inspected facilities
• Change control, lot traceability and supply chain transparency to eliminate unpredictability