Technology for Culture of Megathura crenulata for KLH

Stellar Biotechnologies, Inc., Port Hueneme CA

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Linked publications & trials

Abstract

Development of technology is proposed for the controlled, commercial scale reproduction and rearing of Megathura crenulata, the Giant Keyhole Limpet, for production of Keyhole Limpet Hemocyanin (KLH), an active, non-specific immunotherapeutic adjuvant widely used in biomedical research and specifically in the treatment of certain cancers. The specific aims of Phase I were achieved by: 1) Developing a method to control spawning; 2) Developing procedures for hatching and rearing larvae through metamorphosis; 3) developing suitable diets for growing adult Megathura in captivity; and 4) demonstrating the quantity and quality of KLH from specimens grow in captivity are comparable to those measured in wild populations. In Phase II we propose to: a) Develop and optimize diets for Megathura post-larvae and sustained KLH production; b) Optimize culture methods and stage-specific aquaculture systems for long-term maintenance of KLH-producing stock suitable for commercial scale production; c) Perfect reliable commercial procedures for non-lethal extraction and purification of KLH from aquaculture stock; d) Develop Standard Operating Procedures and establish Good Manufacturing Practice (GMP) standards for KLH produced from aquaculture; and e) In conjunction with prospective Phase III partners, develop a comprehensive business plan for scale-up of our company to meet forecasted KLH demand. PROPOSED COMMERCIAL APPLICATION: The proposed research will create a reliable commercial source of clinical grade KLH for use by pharmaceutical producers and the medical research community. Additionally, the research will create a source of live Megathura crenulata for use in the continuing effort to identify and purify new pharmaceutical compounds, and a supply of juvenile Megathura for restoration of the native population depleted by commercial harvest of the resource for KLH production.