Stellar Biotech supplies the protein Keyhole Limpet Hemocyanin (KLH) to biotechnology and pharmaceutical companies for use in therapeutic vaccines, assessing immune function, and, in immunotoxicology studies, for monitoring the immunomodulatory effects of drug candidates
According to the firm, demand for KLH – produced from Giant Keyhole Limpets (Megathura crenulata) – has led to the scaling-up and expansion of its facility in Los Angeles, California.
“The use of KLH as a carrier for therapeutic vaccines is driving planning,” Stellar spokesperson Gary Koppenjan told Biopharma-Reporter.
KLH protein formulations are intended for conjugation as a carrier molecule in therapeutic vaccines. Stellar’s customers include Araclon Biotech, which is developing beta amyloid-targeting active immunotherapies for neurodegenerative diseases with a primary focus on Alzheimer's disease, and Amaran Biotechnology, a biopharmaceuticals manufacturer based in Taiwan that manufactures a KLH conjugate vaccine for OBI Pharma.
“The successful commercialization of one or more of drug development pipelines, especially in a major indication, could have a significant impact on KLH supplies,” said Koppenjan.
“We estimate that commercial-scale vaccine manufacturing could require multiple kilograms of GMP grade KLH per year. This step change in demand would have a significant impact on the industry’s ability to sustainably produce sufficient quantities of KLH.”
Financial details of the expansion have not been divulged, but this comes two years after the firm’s first phase scale up at the Port of Hueneme site.
“As a small biotech company, we are staging the project so we can expand our core aquaculture infrastructure while minimizing upfront costs.”
Bring forth the mollusk
According to Koppenjan, Stellar is the only company that has the ability to produce grow the Giant Keyhole Limpet in a controlled and fully traceable aquaculture environment.
“These systems include specialized infrastructure, systems for spawning, larval development, and maturation of limpets, recirculating seawater supply systems and environmental controls and monitoring. Wild sources of KLH, of course, are subject to the variability of water quality and conditions along the California coast.”
The KLH protein is then extracted from the aquaculture-raised limpets through a process similar to donating blood. The process does not harm the animal and Stellar is able to extract KLH multiple times per year from the same animal, Koppenjan said.
“We utilize standard biotech industry chromatography and filtration methods to purify the KLH-rich hemolymph that we extract from the limpets.
“Since the native KLH molecule is a large (~4-8 MDa) and highly glycosylated, it is sensitive to parameters such as buffer composition, protein concentration and flow rate, and we have completed years of process development work to optimize the process to produce a consistent, potent product.”