Spectrum Chemical Launches new bioCERTIFIED™ Products to Support Global Demand for New Vaccines, Therapeutics and Other Biopharmaceuticals

Growing portfolio of chemicals part of a larger quality management system that sets new standards in bioprocessing

GARDENA, Calif.–(BUSINESS WIRE)–#biopharmaceuticalmanufacturing—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.”

Bioprocessing Products from Pilot to Production

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.

About Spectrum Chemical Mfg. Corp.

Celebrating more than 50 years in business, Spectrum Chemical Mfg. Corp. is a leading global provider of fine chemicals, laboratory equipment and supplies serving more than 120 industries in 70 countries. The company offers more than 250,000 products in laboratory, scale-up and bulk quantities including the largest selection of USP-NF-FCC-BP-EP-JP chemicals in the world. The company’s capabilities include extensive analytical testing of its products in three state-of-the-art facilities as well as provides scientific documentation with supply chain transparency and change control required for quality-driven industries. For more information, visit SpectrumChemical.com.

Contacts

Media Contact: Sandra Oak, Nsight Public Relations, 321-591-1508, [email protected]

Company Contact: Jobe Dubbs, Vice President, Marketing, Spectrum Chemical, 310-359-9529, [email protected]