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Port Hueneme Cbc Base, CA, United States

Stellar Biotechnologies | Entity website

Stellar Biotechnologies is the leader in sustainable manufacture of Keyhole Limpet Hemocyanin (KLH). We serve the growing demand for this essential molecule and we are focused on applying our expertise to the rapidly-evolving field of immunotherapy development ...

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 290.34K | Year: 2001



Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 97.70K | Year: 2000

Not Available In recent years, dramatic achievements in the area of semiconductor technology have resulted in improved capabilities in such areas as image processing, radar data processing, and voice data processing. However, in order to be useful in many applications

Agency: National Science Foundation | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 94.63K | Year: 2008

This Small Business Innovation Research Phase I project develops methods for the reliable control of settlement and metamorphosis of larval stages of Megathura crenulata (the giant keyhole limpet) to support the production of commercial quantities of Keyhole Limpet Hemocyanin (KLH), a unique and medically valuable marine natural product. Unlike many other prospective medical products from marine organisms, KLH is already in extensive use as an immuno-stimulant, including in over 20 KLH-based clinical trials of therapeutic vaccines. KLH is commonly produced from animals harvested from the finite and fragile natural populations of California and Northern Baja California. With the potential success of one or more of these KLH-based cancer vaccines, the commercial market for KLH could exceed $50 million and place extreme pressure on the species. The broader impacts of this research are significant to the development of new medicines and the preservation of a threatened marine species. Therapeutic vaccines are a promising new class of treatment for cancer, arthritis, and other debilitating chronic diseases; several of these vaccines rely on the proven safety and efficacy of KLH?s immuno-stimulatory properties for their therapeutic effects. Although the natural population of M. crenulata cannot sustain the quantities of KLH required for commercial vaccine products, aquaculture technology has the potential to overcome this supply constraint. Reliable methods for controlling the larval stages of the M. crenulata life cycle are the key to large-scale aquaculture, and could eliminate the biomedical industry?s dependence on wild-harvested animals for commercial KLH supplies.

Lebrec H.,Amgen | Hock M.B.,Amgen Inc. | Sundsmo J.S.,Stellar Biotechnologies | Mytych D.T.,Amgen Inc. | And 6 more authors.
Journal of Immunotoxicology | Year: 2014

The T-cell-dependent antibody response (TDAR) is a functional assay used in immunopharmacology and immunotoxicology to assess ability to mount an antibody response to immunization. Keyhole limpet hemocyanin (KLH) is extensively used as the immunogen of choice in non-clinical and clinical settings. Native KLH is comprised of high molecular weight (HMW; 4-8 MDa) assemblies of KLH subunit dimers (>600-800kDa). It is not known how the different forms (HMW vs subunit) and manufacturing processes (commercial sources) may impact the nature of anti-KLH immune responses (e.g. magnitude and inter-animal variability). Anti-KLH IgM and IgG responses were studied in Sprague-Dawley rats immunized with different forms and commercial sources of KLH: 100μg of HMW KLH from two different sources or subunit KLH from three different sources. Biophysical and biochemical analyses were conducted to characterize the KLH formulations. Anti-KLH IgM and IgG responses were measured using a proprietary indirect quantitative electrochemiluminescence immunoassay. The HMW KLH preparations showed a greater number of sub-visible particles (2-150μm size range) than the subunit KLH preparations. All HMW KLH and all subunit KLH were equivalent on SEC (hydrodynamic volume), PAGE (size and charge), and SDS-PAGE (molecular radius). Robust primary and secondary anti-KLH responses were detected for both sources of HMW KLH. The subunit KLH immunizations resulted in lower IgG and IgM responses compared to the HMW KLH, with the exception of Stellar Biotechnologies subunit KLH that produced both robust primary and secondary responses, which approached the HMW KLH responses. Inter-animal variability for IgM and IgG responses was lower with HMW KLH than with subunit KLH. In conclusion, different forms and commercial sources of KLH were associated with different magnitudes and inter-animal variability in IgM and IgG responses, a critical finding to take into consideration when designing TDAR studies for robust immunotoxicology or immunopharmacology testing. © 2014 Informa Healthcare USA, Inc. All rights reserved. Source

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