Stellar Biotechnologies Announces a Strategic Agreement for Marketing and Sales with SAFC©
August 3, 2011
PORT HUENEME, CA (August 3, 2011) -- Stellar Biotechnologies, Inc. "Stellar" (TSX-V: KLH) (U.S. OTC: SBOTF) is pleased to announce they have entered into an agreement for marketing and sales with SAFC®, a business unit of Sigma-Aldrich (NASDAQ: SIAL) a global leader in biopharmaceutical contract manufacturing. Under the agreement, Stellar will produce KLH commercial intermediate and SAFC will sell, distribute and market cGMP-grade HMW KLH (high molecular weight keyhole limpet hemocyanin) that uses only Stellar aquaculture-derived KLH for applications in therapeutic vaccines.
This collaboration is expected to increase access to a scalable source for KLH, a critical immunostimulatory vaccine carrier protein that will enable the transition from clinical research to commercialization of conjugate vaccine platforms, while managing costs and the risk of supply constraints faced by suppliers that rely on the exploitation of the critically limited natural resource.
Stellar will supply all aquaculture-derived KLH intermediate required for production of SAFC cGMP KLH formulations. SAFC will manufacture HMW KLH under cGMP conditions and provide cGMP clinical and commercial manufacturing of bioconjugation services to support the development and manufacture of conjugate vaccines.
SAFC Director of Business Development Tom Gelineau said, "Our agreement with Stellar Biotechnologies reinforces SAFC's commitment to providing high quality products and specialized contract manufacturing resources to global biopharmaceutical customers – from research through commercialization."
Stellar CEO Frank Oakes commented, "The agreement solidifies our position as the only source for a scalable supply of cGMP-grade HMW-KLH for the vaccine business. We have put Stellar's aquaculture KLH supply front and center in combination with what we believe is the most important manufacturer and marketer of cGMP biologics in the world, Sigma-Aldrich's SAFC business unit. This exciting development will allow us to move aggressively forward on our diagnostic programs, knowing that the state-of-the-art quality assurance and production capabilities of SAFC will be providing the backbone for companies seeking the highest quality HMW-KLH available for vaccine developers anywhere in the world. We look forward to continuing growth in this relationship and will begin manufacture of SAFC's initial order as soon as possible."
About High Molecular Weight KLH:
HMW KLH is an ideal carrier molecule for vaccine antigens (substances that promote the generation of antibody and cell-mediated immune responses) against cancers and infectious agents. The combination of an antigen against specific tumor cell-types, conjugated to the highly immunogenic HMW KLH molecule, is the basis for a proven strategy for a new class of drugs known as therapeutic vaccines. Potent yet safe in humans, KLH is highly prized as a critical component of certain therapeutic vaccines including ones for lymphoma, bladder, breast, colon and other cancers as well as other indications including Alzheimer's, rheumatoid arthritis, lupus and others.
About SAFC®: SAFC is the custom manufacturing and services business unit of Sigma-Aldrich Corporation (SIAL). They are recognized as a top 10 global fine chemical supplier and trusted manufacturer of specialty chemicals and biologics for the life science and high technology industries. Utilizing global "Centers of Excellence" and dedicated manufacturing facilities, SAFC is often able to resolve development and manufacturing challenges and accelerate the production of custom materials. Their rich portfolio includes high-purity inorganic materials for high technology applications, cell culture products, services for biopharmaceutical manufacturing and biochemical production, and complex, multi-step organic synthesis of APIs and key intermediates. For more information about SAFC, visit www.safcglobal.com.
About Sigma-Aldrich (SIAL): Sigma-Aldrich is a leading Life Science and High Technology company. Its biochemical and organic chemical products and kits are used in scientific and genomic research, biotechnology, pharmaceutical development, the diagnosis of disease and as key components in pharmaceutical and other high technology manufacturing. The Company has customers in life science companies, university and government institutions, hospitals, and in industry. Over one million scientists and technologists use its products. Sigma-Aldrich operates in 40 countries and has 8,300 employees providing excellent service worldwide. Sigma-Aldrich is committed to Accelerating Customer Success through Innovation and Leadership in Life Science, High Technology and Service. For more information about Sigma-Aldrich, please visit its award-winning Web site at www.sigma-aldrich.com.
SAFC and Sigma-Aldrich are registered trademarks of Sigma-Aldrich Co. LLC.
About Stellar Biotechnologies, Inc. Stellar Biotechnologies, Inc. (TSX-V: KLH) (U.S. OTC: SBOTF) (www.StellarBiotechnologies.com) is the world leader in sustainable manufacturing of pharmaceutical grade KLH (Keyhole Limpet Hemocyanin). This evolutionary protein has a highly complex structure that makes it ideal for use in human and animal vaccines and diagnostic products. With partners and customers, its flagship Stellar KLH products are in the clinic, and on the way to being established as the only sustainable, long-term pharmaceutical source. Stellar Biotechnologies was founded to address the growing demand for renewable, commercial-scale supplies of high-quality, GMP-grade KLH. Stellar has developed leading practices, facilities and proprietary capabilities to address this need.
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