NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--Spectrum Chemical Mfg. Corp., a leading global manufacturer and distributor of fine chemicals, laboratory equipment and supplies, announced today that the Company will distribute raw materials for use in biopharmaceutical manufacturing from Macco Organiques. Initial products include USP, EP, JP, FCC, and ACS grade inorganic salts commonly used in biopharmaceutical manufacturing. All the products are manufactured and warehoused under strict cGMP processes, including supply chain verification and temperature controlled warehouses.
Right Materials from the Start
Spectrum Chemical CEO Randy Burg said, "We have consistently invested in facilities, personnel and regulatory certifications to help ensure that our drug manufacturing customers get the right materials from the start, minimizing downstream production risks. We have agreed to work with Macco because of their strong presence in this market and their ability to meet the highest standards in the industry."
Macco is a leading producer of inorganic salts for parenteral drug manufacturing, covering a wide range of needs in the biopharma and health care industry. Certifications and registrations include GMP ICH Q7, FSSC 22000, ISO 9001, FDA inspected, Registrations at MHLW & PMDA Japan, CoS/CEP, US DMF, Jap DMF, ASMF Quality Standards, and USP/EP/BP/JP/FCC/ACS graded products.
bioCERTIFIED™ Program from Spectrum Chemical
Production of biopharmaceuticals such as vaccines, antibodies and recombinant proteins requires a more stringently-controlled process than traditional small molecule drugs. Certifying that raw materials are free of contaminants or particles is critical to robust bioprocessing systems. Spectrum's new bioCERTIFIED program goes beyond its standard testing that every chemical brought into its facilities undergoes, offering additional bioburden, endotoxin and elemental impurities controls and testing.
With four established analytical laboratories that perform more than 15,000 tests per year, Spectrum Chemical continues to expand its footprint, having recently added over 42,000 square feet of manufacturing, laboratory, and warehousing in its New Brunswick headquarters. The facilities offer modern biopharma industry standard CFR 210/211 cGMP packaging capabilities and ISO 8 controlled environment. Additional expansions totaling more than 100,000 square feet are planned for 2019 and 2020.
About Spectrum Chemical Mfg. Corp.
Spectrum Chemical Mfg. Corp. is a leading global manufacturer and distributor of fine chemicals, laboratory equipment and supplies for a range of industries. Spectrum offers the largest selection of USP chemicals in the world, including laboratory, scale up and bulk quantities. Bicoastal cGMP facilities are FDA registered and inspected, with additional certification to the ISO 9001:2015 standard. Spectrum performs extensive laboratory testing using the most modern instrumentation to ensure the highest quality standards in its four analytical testing laboratories.
The company has recently introduced its new bioCERTIFIED program. Spectrum Chemical’s extensive scientific documentation provides the change control required for quality-driven industries. For more information, visit Spectrum Chemical.com.