Source: PTSM: Pharmaceutical Technology Sourcing and Management
Issue 5,Volume 7
Spectrum Chemical Mfg., a supplier of bulk fine chemicals and pharmaceutical ingredients, opens new facilities in China and augments its custom-synthesis business.
Spectrum Chemical Mfg., a supplier of bulk fine chemicals, excipients, active pharmaceutical ingredients (APIs), intermediates, analytical reagents, biochemicals, laboratory products, and equipment is in an expansion mode. The company opened a new facility in China earlier this year and is enhancing its custom-synthesis business to complement its primary bulk-chemical business.
A core competency of Spectrum is its role as a supplier to the pharmaceutical industry. The company’s chemical portfolio contains more than 15,000 laboratory research and bulk production chemicals, including more than 1200 United States Pharmacopeia–National Formulary (USP–NF) monograph products, making it one of the largest suppliers of USP-NF products, says Paul Burg, founder and chairman of Spectrum. Burg founded Spectrum in 1971 in Southern California, which is also the location of the company’s current headquarters in Gardena, California. In addition to manufacturing, warehousing, and distribution facilities in California, the company has similar operations in New Brunswick, New Jersey. Its facilities are ISO 9001 certified, which is the standard for quality management systems issued by the International Organization for Standardization (ISO) and are approved under current good manufacturing practices (cGMP). In 2007, the company expanded its warehouse and cGMP packaging facilities in New Jersey.
Earlier this year, Spectrum opened new facilities in China. Spectrum started sales and marketing operations in China in 2003 and later opened analytical testing and laboratory facilities in Shanghai. In 2007, Spectrum China Analytical Services, the company’s contract analytical business in China, received ISO 17025 certification as a testing and calibration reference laboratory. With the ISO certification, Spectrum also functions as a third-party analytical services provider in China and provides expertise for companies interested in sourcing and purchasing fine chemicals from China. Other services provided include third-party analytical support, onsite audit and validation services, manufacturing evaluation, documentation, and logistical support.
In February 2011, Spectrum opened a new 30,000-ft2 facility in the Songjiang Industry Zone in Shanghai, which provides expanded analytical testing, manufacturing, warehousing, and distribution capabilities for its global customers. In addition to offering contract analytical services, the company’s facilities in China serve two primary functions: supplying domestic and foreign manufacturers with bulk fine chemicals and providing a base for the company’s sourcing activities in China, which include related analytical testing. “Spectrum’s uniqueness and expertise lie in our understanding of the global supply chain, chemical technologies, and quality standards,” says Craig Recatto, president of Spectrum’s custom-synthesis business. In addition to its range of USP–NF products, Spectrum supplies bulk chemicals in accordance with European, Japanese, and British pharmacopeial standards as well as American Chemical Society (ACS)-grade reagents and chemicals.
A growing part of Spectrum's business is centered around its custom-synthesis capabilities as a chemistry outsourcing partner to the pharmaceutical and biotechnology industries. The company employs over 40 chemists to develop, test, and manufacture pharmaceutical intermediates and APIs ranging from multigram quantities for drug discovery through multiton cGMP commercial manufacture. The company also manufactures DEA (Drug Enforcement Agency) controlled substances (Schedules II-V) and provides full regulatory support to customers for these items. Overall, it has more than 1200 gallons of total reactor capacity and also has glassware research and development and kilo laboratory synthesis suites available for development work. The custom-synthesis business also offers related chemistry services, such as GMP analytical method development and validation, ICH (International Conference on Harmonization) stability studies, and chemistry, manufacturing, and controls (CMC) support.
Recatto sees the company’s custom-synthesis business as synergistic to the company’s bulk-chemical activities. “It builds on our expertise in chemical development and manufacturing,” he says. Also, with increased emphasis on supply-chain integrity, the company’s ability to source raw materials and chemical intermediates from audited manufacturers adds further expertise beyond a strictly contract-manufacturing function. “In an increasingly global and complex pharmaceutical supply chain, the know-how in regulatory and quality systems is crucial,” says Recatto, concluding that such expertise it is an integral part of the company’s business model and growth strategies.