Spectrum Chemical Mfg. Corp. has added 12 new products to its bioCERTIFIED quality management system in response to a recent acceleration in global demand.
“Spectrum Chemical has decades of experience dealing with the ever-changing global regulatory environment,” Jigisha Patel, vice president of global regulatory and compliance for Spectrum Chemical, said, according to a press release. “Due to COVID-19, there is an even greater worldwide demand for chemicals whose quality and safety are thoroughly documented.”
The additions include sugars/carbohydrates, organic and inorganic salts, and preservatives used for cell development, downstream purification and bioprocessing application, as well as polishing and final fill production.
Sodium Chloride UPS, EP is also included in the catalog, commonly used for bioprocessing. Sucrose, USP-NF, EP, JP, ChP, used for upstream cell culture and downstream final fill.
Following production, the products must then undergo testing for endotoxin, bioburden and other impurities, as well as various quality processes and certifications, a press release stated.
“Not only do our chemicals meet regulatory and compliance requirements, our documented change controls and sourcing protocols ensure full supply chain transparency,” Patel said.
According to a press release, biopharmaceutical manufacturers are also required to follow various regulatory and compliance guidelines. The experts constantly work to reduce time to market for new drugs and therapeutics.
“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,” Spectrum Chemical COO Russell Kneipp said.
Aside from its in-house testing service, Spectrum Chemical also specializes in "change control, batch traceability and supply chain transparency to eliminate batch-to-batch unpredictability."
“We have a 50-year track record of providing products with comprehensive scientific documentation to quality-focused industries such as pharma and biopharmaceuticals,” Kneipp said.
The chemical company, established in 2019, has also taken on the task to distribute inorganic salts from Macco Organiques Inc. for parenteral drug manufacturing.