GARDENA, Calif.– 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.
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.
Also included in the new bioCERTIFIED product offering are 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.
