Stellar Biotechnologies has drawn considerable attention over the past year or so for their incredible work developing Keyhole Limpet Hemocyanin (KLH), a high-impact T-dependent carrier protein for naturally catalyzing immune responses (MHC Class I and Class II-restricted), which is generally paired with vaccine antigens to fight cancer and other infectious agents. An extremely potent, yet safe in humans, immunogenic vehicle for delivering tumor-specific antigens, this large-molecule, high molecular weight protein has rapidly become a target of choice for developing therapeutic vaccines, a whole new class of drugs.
 
KLH is widely used across the pharma sector in active immune therapies, but is also making major strides in immune function testing injectables, as is the case with their Stellar KLH™ ELISA Test Kit, which benefits tremendously from being used in combination with the company’s KLH product. The utility of KLH in assessing immune function, for instance where the immunosuppressive efficacy of a given drug needs to be tested or monitored in immunotoxicology studies, is immense all on its own and there is a bright future for the product just in the clinical research end of the pool as an antigen.
 
Pure, high-quality, large-molecule Stellar KLH™ Protein for Vaccine Conjugation is an ideal platform for passing peptides, as well as small proteins or drug molecules of low molecular weight (which aren’t typically immunogenic) in research and therapeutic vaccine applications, with numerous antigen conjugation sites and epitopes available (the part recognized by the immune system). One look at just a smattering of the KLH-based therapeutic vaccines in the global development pipeline says it all really, with idiotype vaccines for lymphoma and VEGF (vascular endothelial growth factor) vaccines for various cancers in the works, alongside such innovative uses of this proven platform as a TNF vaccine (tumor necrosis factor alpha, which regulates immune cells) for hypertension and even a vaccine aimed at treating nicotine dependency.
 
The powerful combination of potency based on premium structural biochemistry and demonstrable tolerability/safety, easily explains the immense popularity KLH has obtained as a carrier protein and a closer look at the company’s KLH supply chain fundamentals tells you the rest of the story. Now, KLH doesn’t just come from anywhere mind you and you can’t just manufacture this stuff in a lab. The only way to get your hands on this incredible substance is to expertly extract it from the hemolymph of the Giant Keyhole Limpet (Megathura crenulata, in fact it is the only species in the genus), a rare type of marine sea cucumber which lives only in a specific stretch of ocean running from the rocky coastal waters off of Southern California on down to Baja.
 
By 2012, SBOTF leapt to the forefront of the KLH space and became a biopharma hot shot by reaching a true milestone in aquaculture science, turning all other operators in the space into artisan farmers reliant on the scant/sensitive wild populations of this amazing creature, as decades of marine science eventuated in a mastery of the Giant Keyhole Limpet lifecycle over multiple generations and the emergence of a fully functional KLH aquacultural manufacturing facility. Moreover, this facility is strategically located with direct access to the native population, making the manufacturing facility itself a key proprietary asset that cannot be readily duplicated by competitors. The company’s ability to produce large volumes of consistent, quality-controlled KLH from a sustainably cultivated population using proprietary methods, is a potential biopharma bonanza and they have already established themselves as a provider of fully traceable KLH besides (from native source to finished product). All of SBOTF’s product is manufactured according to current cGMP standards and they even offer research-grade (non-GMP) KLH for various advanced research applications.
 
The recent (Feb 12) poster presentation by SBOTF at Aquaculture America 2014 in Seattle of their new methodology for rapid, cost-effective KLH assay authentication (developed alongside California State University, Fullerton), which verifies if hemocyanins are of non-Megathura crenulata source or not, clearly showcased the company’s commanding lead in the KLH space. COO of SBOTF, Catherine Brisson, Ph.D., noted how origin material verification was the bedrock for quality authentication in this industry and she highlighted the company’s continual, internal processing of advanced analytical methodologies related to KLH production, stressing this as perennial edge SBOTF has held over competitors in both manufacturing and quality control. This new methodology firmly reinforces the company’s market position and is something of a PR coup.
 
As a hallmark of such continued success, SBOTF has just been named (Feb 13) to the 2014 TSX Venture 50®, an exclusive ranking of the top TSXV players in cleantech, diversified industries, life sciences, mining, and oil/gas tech. In fact, SBOTF is the top ranked company across all of the sectors in the list, a bold endorsement from this TMX Group (owns the Toronto Stock Exchange and Toronto Venture Exchange) measuring stick of the strong performance the company has achieved and is achieving.
 
Learn more about Stellar Biotechnologies, Inc. at www.StellarBiotechnologies.com
 
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