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Spectrum Chemical launches new bioCERTIFIED™ products to support global demand for new vaccines, therapeutics and other biopharmaceuticals

Spectrum Chemical
18 Mar 2022
Ellie Abbott
Biochemist

Product news

Spectrum Chemical Mfg. Corp, a global provider of fine chemicals, laboratory equipment, and supplies, announced that 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’ 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 inorganics salts from Macco Organiques Inc. for parenteral drug manufacturing. The company also offers hundreds of unique cell culture additives for upstream bioprocessing.

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Biopharmaceutical AdvancesBiopharmaceutical advances follow the development of pharmaceuticals derived from biotechnology, also known as biotechnology medicines. Biopharmaceuticals may be produced from cell lines, plants, or microbial cells. Important considerations of biopharmaceutical use include application, cost, production process and purification.Bioprocessing / FermentationBioprocessing is the use of biological materials to perform commercial, scientific or medical research processes. Biological materials used include cells, enzymes and organisms. Usually bioprocessing requires a batch or continuous bioreactor such as a fermentor or cell culture system. The advantages of using a reactor include high productivity, easy configuration, adjustable values and automation.BiopharmaceuticalsBiopharmaceuticals are proteins and other compounds (such as nucleic acids) produced by living organisms that have uses as therapeutics or for in vivo diagnostics. The most well known example of a biopharmaceutical product, and the first to be approved for therapeutic use, was recombinant human insulin.BiotherapeuticsBiotherapeutics are proteins and other compounds (such as nucleic acids) produced by living organisms that have uses as therapeutics or in <i>in vivo</i> diagnostics. The most well-known example of a biotherapeutic product, and the first to be approved for therapeutic use, was recombinant human insulin.Vaccine DevelopmentVaccine development focuses on creating immunizations to protect against infectious diseases. The process involves identifying antigens, developing and testing vaccine efficacy, and ensuring safety through preclinical testing and multiple clinical trial phases. Scientists use various approaches, including weakened or inactivated viruses, protein subunits, or mRNA. Advanced platforms and rapid diagnostic tools aid in vaccine research and testing. Explore vaccine development solutions in our peer-reviewed product directory; compare products, read reviews, and get pricing directly from manufacturers. TherapeuticsTherapeutics are treatments designed to alleviate or cure diseases. These include pharmaceuticals, biologics, and gene therapies, which work by targeting specific disease mechanisms. Advances in personalized medicine and biologics offer new hope for patients with conditions that were previously difficult to treat. Browse our peer-reviewed product directory to find therapeutic solutions for various diseases; compare products, check user reviews, and get pricing directly from manufacturers.

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