Meet increasing quality, safety and regulatory requirements with confidence with Spectrum Chemical's bioCERTIFIED™ Quality Management System and products for biopharmaceutical manufacturing.
Featuring expanded laboratory testing, certifications and documentation, our bioCERTIFIED portfolio is tailored to each customer’s unique requirements from biopharmaceutical drug discovery to pilot and scale-up to production.
bioCERTIFIED products help you simplify, standardize and streamline bioprocessing to ensure success and speed time to market. And they are backed by Spectrum Chemical's "100% Tested and 100% Transparent" guarantee. All raw materials and finished goods are subject to in-house testing in our cGMP-compliant facilities to ensure that all chemicals and ingredients meet stringent quality standards.
For parenteral applications in which a biological drug enters directly into the bloodstream, even more stringency is required to ensure a product is endotoxin-free with minimal bioburden. New USP 232/233 requirements for elemental impurities put even more demand on the certifications for raw materials. bioCERTIFIED products have undergone additional testing for bioburden, endotoxin and elemental impurities.
Spectrum Chemical's extensive knowledge and experience in the changing global environment also ensure that our products — and YOURS — are compliant with regulatory standards. Additionally, documented change controls and sourcing ensure full supply chain transparency.
With Spectrum Chemical bioCERTIFIED materials, you gain an industry-leading support team and strict quality and certification processes to ensure product consistency, predictability and performance. Think of us as an extension of your quality control system. We provide comprehensive testing, scientific documentation and customization to meet your requirements, reduce your workload and accelerate biopharmaceutical production.
- Full testing for every lot — Standard tests by lot include bioburden, endotoxin and elemental impurities. Additional tests available.
- Comprehensive regulatory and scientific documentation — Professionally prepared dossiers succinctly provide all required documentation on pilot, scale-up and production chemicals.
- Change control and batch traceability — Complete supply chain transparency and traceability.
- Three in-house analytical testing labs — U.S. locations are ISO 9001:2015 while Shanghai, China, facility is ISO 17025.
- Extensive product breadth and availability — Globally sourced products include amino acids, biological buffers, inorganic salts, sugars, carbohydrates, cleaning-in-place solutions and more.
- Biopharm industry standard CFR 210/211 cGMP packaging facilities — Custom and batch-specific packaging, labeling, production sizes, manufacturing solutions and documentation to meet specific customer requirements.
- Modern ISO Class 8 certified clean packaging facilities
- Scale-up and streamlined speed to market support — Flexibility to accommodate different requirements from pilot to small-medium pre-packaged and bulk sizes.
- Industry-leading support — Expert technical service and consultative support for sales, regulatory, quality management, purchasing and manufacturing teams.
- Auditing and quality management controls — Suppliers and processes are regularly audited; corrective and preventive actions (CAPAs) are quickly addressed.
Professional Scientific Documentation
As part of Spectrum's expanded bioCERTIFIED™ program, the company offers hundreds of professionally prepared dossiers. Providing such documentation on pilot, scale-up and roduction chemicals mitigates downstream financial risks for biomanufacturers by avoiding costly downtime.