Cancer vaccines in development at Bayer, Neovacs and other companies use keyhole limpet hemocyanin (KLH) as an adjuvant. To secure supply SAFC is sourcing aquaculture-derived KLH from Stellar.
“SAFC will be providing the backbone for companies seeking the highest quality high molecular weight (HMW) KLH available for vaccine developers anywhere in the world”, Frank Oakes, CEO of Stellar, said.
Using KLH intermediate sourced from Stellar, SAFC is producing cGMP (current good manufacturing practice) HMW KLH to sell to vaccine companies. SAFC will also use supplies to offer cGMP production, from clinical to commercial-scale, and bioconjugation services.
With SAFC handling supply of cGMP HMW KLH for vaccines Stellar will “move aggressively forward on [its] diagnostic programmes”, Oakes said. Product development at Stellar focuses on KLH’s applications as an immune-stimulating antigen in drug screening and toxicology.
Securing a source
Keyhole limpets are only found along a stretch of the Pacific Coast from California down to Baja, Mexico. At a meeting in 2006, Jack Engle, of the University of California, Santa Barbara, said he was very concerned about the impact commercialisation of KLH vaccines may have on limpet populations.
With demand set to continue rising as vaccines reach commercialisation a more secure and sustainable source was needed. Using a US Government grant Stellar had worked to meet this need by developing aquaculture technologies and non-lethal hemocyanin extraction methods.
Stellar now has an 8,200 sq ft aquaculture, research and manufacturing facility on the California coast. Using the technology it has developed Stellar believes it can scale-up production to meet the upturn in demand if vaccines using KLH reach commercialisation.
Sourcing the limpets from a controlled environment also reduces regulatory concerns about the potential for contamination with infectious diseases. Finally, the non-lethal extraction methods are a more ethical alternative to the previous lethal process that drained blood from the limpets.