PORT HUENEME, CA--(Marketwire - March 19, 2013) - Stellar Biotechnologies, Inc.
("Stellar" or "the Company") (OTCQB: SBOTF
) (TSX VENTURE: KLH
), the world leader in sustainable manufacture of Keyhole Limpet Hemocyanin (KLH), today announced the Company has submitted a Type IV Biologics Master File (BB-MF) to the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) for its subunit KLH.
A Biologics Master File is a confidential, detailed dossier submitted to the FDA which contains the proprietary information on the manufacture and safety of a drug component.
Stellar continually updates and maintains master files at the FDA for its KLH products. These files allow Stellar to provide controlled access to a single source of information on file with the FDA, for customers to reference as part of their product applications.
This new BB-MF is intended to support Stellar's KLH customers who file applications under the CBER division, thus expanding applicability of the Company's KLH for broader uses.
Stellar's goal is to help accelerate the regulatory approval process for products that use the Company's KLH. Only Stellar KLH is derived from proprietary, cultured keyhole limpet colonies. This allows Stellar to deliver an unprecedented level of control over its KLH quality and performance; benefits valued by vaccine manufacturers and drug developers using KLH.
"Stellar is always looking for effective ways to support our customers' applications through the regulatory process," commented Catherine Brisson, Chief Pharmaceutical Officer at Stellar Biotechnologies. "We are very pleased to have this master file submitted to CBER. By ensuring that the information required by FDA is accessible, we can facilitate regulatory approvals for KLH-based products."
For more information:
Visit www.StellarBiotech.com and the KLH knowledge base www.KLHSite.com.
About Stellar Biotechnologies, Inc.
Stellar Biotechnologies, Inc. (OTCQB: SBOTF) (TSX VENTURE: KLH) is the world leader in sustainable manufacture of Keyhole Limpet Hemocyanin (KLH). KLH is an important immune-stimulating protein used in wide-ranging therapeutic and diagnostic markets. Potent, yet proven safe in humans, KLH operates as both a vital component for conjugate vaccines (targeting cancer, autoimmune, and infectious diseases) as well as an antigen for measuring immune status. 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. To receive regular updates, enter email at bottom of http://stellarbiotechnologies.com/investors/news_releases/
Forward Looking Statements
There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Readers should not place undue reliance on such statements. Except in accordance with applicable securities laws, the Company expressly disclaims any obligation to update any forward-looking statements or forward-looking statements that are incorporated by reference herein. This news release does not constitute an offer to sell, or a solicitation of an offer to buy any of the Company's securities set out herein in the United States, or to, or for the benefit or account of, a U.S. Person or person in the United States. Neither TSX Venture Exchange nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of these releases.