Press Release | Spectrum Chemical Expands bioCERTIFIED™ Products Portfolio to Meet Growing Demand for Biologics

Spectrum Chemical Expands bioCERTIFIED™ Products Portfolio to Meet Growing Demand for Biologics

Visit Spectrum Chemical Booth #604 at BPI US West in San Diego, February 28-March 2, 2023

GARDENA, CA--(February 28, 2023)--Spectrum Chemical Mfg. Corp, a leading global provider of specialty, fine and cGMP chemicals, announced today the expansion of its bioCERTIFIED product line with the addition of multiple new raw materials for use in R&D and biopharmaceuticals production.

Jim Luchsinger, Spectrum Chemical’s Vice President of Business Development and International Distribution, said, "Our high-purity bioCERTIFIED raw materials are uniquely suited to meet the needs of biopharma manufacturers whether it involves drug discovery or final production. Our products undergo extensive testing in our own analytical laboratories and are supported with rigorous documentation to meet global regulatory and compliance requirements.”

The company made the announcement during the BioProcess International (BPI) US West conference in San Diego.

The new bioCERTIFIED products include an expanded line of biological buffers, which are vital for modeling biological systems and have applications in cell culture, bioprocessing, purification and formulation. Many cellular processes thrive only in a relatively small pH range. A buffer solution is used to maintain desired pH.

The new bioCERTIFIED products also include amino acids for protein purification and formulations, sugars and carbohydrates to stabilize proteins and prevent damage during cell culture and final fill, and pH adjusters such as sodium hydroxide pellets to help neutralize acids.

With the new additions, Spectrum Chemical now offers approximately 100 bioCERTIFIED products for both upstream and downstream bioprocessing, as well as hundreds of unique cell culture additives for biosimilars and biologics.

Each bioCERTIFIED product undergoes complete lot analysis including expanded testing for endotoxin, bioburden and elemental impurities. Materials also incorporate additional quality control processes in cGMP facilities and include certifications and scientific documentation for change control, batch traceability and supply chain transparency.

Jim Luchsinger, Spectrum Chemical’s Vice President of Business Development and International Distribution, said, “Our high-purity bioCERTIFIED raw materials are uniquely suited to meet the needs of biopharma manufacturers whether it involves drug discovery or final production. Our products undergo extensive testing in our own analytical laboratories and are supported with rigorous documentation to meet global regulatory and compliance requirements.”

Leveraging more than 50 years of experience in fine chemicals, active pharmaceutical ingredients (APIs) and excipients with multiple facilities and in-house analytical laboratories, Spectrum Chemical continues its commitment to supply customers worldwide with the essential quality products necessary for use in drug discovery and development, clinical trials and the manufacture of biotherapeutics, vaccines and other pharmaceuticals.

In addition to its bioCERTIFIED product offering, Spectrum Chemical is the exclusive distributor of inorganics salts from Macco Organiques Inc. for parenteral drug manufacturing. Spectrum Chemical also markets and distributes TRIS AMINO™ AC USP/EP and BIS-TRIS Biologics grade buffers from ANGUS Chemical Company, as well as BioHale® Sucrose and BioHale Trehalose Dihydrate excipients from DFE Pharma for biomolecules in parenteral, inhalation and ophthalmic applications.

About Spectrum Chemical

Celebrating more than 50 years in business, Spectrum Chemical Mfg. Corp. is a leading global provider of chemicals, laboratory equipment and supplies serving more than 120 industries in 70 countries. The company offers more than 45,000 chemicals in laboratory, scale-up and bulk quantities including the largest selection of USP-NF-FCC-BP-EP-JP chemicals in the world. Spectrum Chemical’s capabilities include extensive analytical testing of its products throughout its three state-of-the-art facilities, as well as scientific documentation with supply chain transparency and change control required for quality-driven industries. The company also distributes more than 60,000 consumable supplies, safety items and equipment.

For more information, visit SpectrumChemical.com.

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Jim Luchsinger | Vice President, Business Development and International Distribution

Media Contacts

Media Contact: Sandra Oak, Nsight Public Relations, 321-591-1508, soak@nsightpr.com

Company Contacts: Jobe Dubbs, Vice President, Marketing, Spectrum Chemical, 310-359-9529, jdubbs@spectrumchemical.com

About Spectrum Chemical Mfg. Corp.

Spectrum Chemical Mfg. Corp. leverages more than 50 years of expertise in sourcing, QC testing and repackaging of chemicals provided by other manufacturers to meet the needs of organizations in highly regulated industries. Spectrum Chemical is a certified women’s business enterprise (WBE).

Over 200 Spectrum Chemical employees work together across three worldwide locations. We offer more than 45,000 chemicals in laboratory, scale-up and bulk quantities, as well as more than 60,000 supplies, equipment, consumables and PPE. In all, we represent 250 manufacturers and serve 120 industries in 70 countries.

We conduct in-house QC testing by lot to safeguard quality at each of our facilities and provide extensive regulatory and scientific documentation to ensure compliance. We also offer change control, lot traceability and supply chain transparency to eliminate unpredictability. Our products are packaged and stored under cGMP in FDA-registered and inspected facilities.

With our diverse product portfolio and relentless focus on quality, we deliver security of supply to minimize risk and raw material variability, as well as offer highly personalized service and practical consultations to earn your trust and exceed expectations.