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