GARDENA, Calif.– Spectrum Chemical Mfg. Corp., a leading global provider of fine chemicals, laboratory equipment and supplies, announced today it has added 12 new products to its rapidly growing bioCERTIFIED™ quality management system and chemicals portfolio for biopharmaceutical manufacturing.
Launched in 2019, the company’s bioCERTIFIED products undergo additional testing for endotoxin, bioburden and elemental impurities, as well as incorporate additional quality control processes and certifications. Combined, these efforts help biopharmaceutical manufacturers meet regulatory and compliance requirements while reducing time to market for new drugs and therapeutics.
“We have a 50-year track record providing products with comprehensive scientific documentation to quality-focused industries such as pharma and biopharmaceuticals,” said Russell Kneipp, chief operating officer for Spectrum Chemical. “All bioCERTIFIED products carry our ‘100% tested, 100% transparent, 100% trusted’ guarantee, reflecting our ongoing commitment to support biopharmaceutical development and production of biologics for new vaccines, therapeutics and an array of future applications.”
The addition of the 12 new bioCERTIFIED products includes sugars/carbohydrates, organic and inorganic salts, and preservatives used in a wide range of bioprocessing applications from upstream cell culture development to downstream purification, polishing and final fill production.
The new products include Sodium Chloride UPS, EP, an inorganic salt that is a staple in bioprocessing with multiple applications ranging from cell culture to downstream purification and polishing, as well as Sucrose (Beet-Derived), USP-NF, EP, JP, ChP, a sugar/carbohydrate for upstream cell culture and downstream final fill. Sucrose is one of the most widely used stabilizers in drug products.
In addition to undergoing stringent in-house testing in cGMP-compliant facilities, bioCERTIFIED products offer change control, batch traceability and supply chain transparency to eliminate batch-to-batch unpredictability, as well as a wide range of product and packaging options for biopharmaceutical R&D, scale-up and production.
“Spectrum Chemical has decades of experience dealing with the ever-changing global regulatory environment. Due to COVID-19, there is an even greater worldwide demand for chemicals whose quality and safety are thoroughly documented. Not only do our chemicals meet regulatory and compliance requirements, our documented change controls and sourcing protocols ensure full supply chain transparency,” said Jigisha Patel, vice president of global regulatory and compliance for Spectrum Chemical.
In addition to its bioCERTIFIED product offering, Spectrum Chemical is the exclusive distributor of inorganic salts from Macco Organiques Inc. for parenteral drug manufacturing. The company also offers hundreds of unique cell culture additives for upstream bioprocessing.
