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From: pedley (Rep: 24)Date: 05/24/2018 08:08
Forum: Stellar Biotechnologies, Inc - Msg #48Thread #674011202 (Rec: 0)
Stellar Achieves Robust Viral Clearance for Manufacturing Process

LOS ANGELES, May 24, 2018 /PRNewswire/ -- Stellar Biotechnologies, Inc. (Nasdaq: SBOT), a leading manufacturer of a key protein utilized in multiple immunotherapy development pipelines targeting Alzheimer's, lupus and cancer, among other diseases, today announced that third-party trial results have demonstrated that the company's KLH manufacturing methods achieve robust viral clearance. This clearance step is a key quality assurance milestone under Stellar's initiatives to increase the scalability and throughput capacity of its manufacturing processes. Results from testing completed by Texcell, a contract testing organization for viral safety, demonstrated that Stellar's manufacturing process for its most widely used formulation effectively removes three representative viruses, and meets suggested regulatory criteria for robustness. While routine quality testing has never detected the presence of viruses in Stellar KLH, one of the principal approaches to control the potential presence of viruses in biological products is to purposely introduce viruses in a test environment and demonstrate the capacity of the production process to remove them. Stellar Executive Vice President of Corporate Development, Gregory T. Baxter, PhD, said that the company aims to roll out manufacturing optimizations ahead of the next phase of its customers' clinical studies, and will continue to routinely test for viruses and validate the viral removal of its manufacturing processes as needed."KLH is a key component for the success of multiple immunotherapies under development and Stellar is committed to expanding our manufacturing capacity and validating our quality systems as our customers advance toward pivotal Phase 3 clinical studies," said Dr. Baxter. To produce Stellar KLH, hemocyanin protein is extracted from its native source using Stellar's patented process and then purified and manufactured into various grades and formulations. Due in part to its controlled aquaculture source and manufacturing methods, Stellar KLH has been shown to produce a vigorous primary and secondary immune responses. Researchers interested in obtaining Stellar KLH, or obtaining technical specifications for research or GMP-grade KLH, may contact Stellar business development department at (805)488-2800 or KLHinfo@stellarbiotech.com.

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During the quarter, Stellar continued to advance its optimization and expansion initiatives, which are intended to increase the scalability of the company's KLH production and manufacturing processes. A number of therapeutic vaccines that utilize the KLH protein as a carrier molecule are currently in clinical studies by third parties. While the outcomes of these clinical trials cannot be predicted, the company is preparing for the possible impact that favorable clinical results could have on the KLH market and Stellar's supply capabilities. Results from the first of these trials are anticipated to be announced during the summer of 2018, but there can be no certainty as to when our customers will issue their findings.Frank Oakes, Stellar's President and Chief Executive Officer, said that the heightened activity now is the result of multiple companies with KLH-conjugated vaccines entering Phase 2 trials in the past two years. "We are eagerly awaiting upcoming developments from these clinical studies and continue to work closely with current and prospective customers to ensure long-term support of their immunotherapy programs."

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