SAFC signs KLH agreement with Stellar Biotechnologies
Stellar will provide limpet blood produced in a controlled environment for cGMP manufacturing
Stellar Biotechnologies is to provide pharmaceutical grade keyhole limpet hemocyanin (KLH) to SAFC, the contract manufacturing business unit of Sigma-Aldrich in the US.
KLH, found in limpet blood, has adjuvant properties and is a critical component of certain therapeutic vaccines including those for lymphoma, bladder, breast, colon as well as other indications including Alzheimer's, rheumatoid arthritis and lupus.
According to Dave Backer, SAFC’s director of marketing and business development, the company previously hired someone to catch limpets out of the ocean, bleed them and throw them back, but because limpets are feeder filters there was a danger that contaminants in the seawater would be present in the KLH.
Backer said Stellar has taken a different and sustainable approach by applying its expertise in aquaculture to raising the limpets in a controlled environment. The Californian company’s KLH is contaminant-free and each limpet can be tracked because it is RFID-tagged.
Using Stellar’s aquaculture-derived KLH intermediate, SAFC will produce cGMP KLH formulations, as well as offer cGMP manufacturing from clinical to commercial scale and bioconjugation services to support the development and manufacture of conjugate vaccines.
The collaboration is expected to increase access to a scalable source for KLH that will enable the transition from clinical research to commercialisation of conjugate vaccines.
Stellar chief executive Frank Oakes said: ‘SAFC will be providing the backbone for companies seeking the highest quality HMW-KLH available for vaccine developers anywhere in the world.’
With SAFC handling the supply of cGMP HMW KLH for vaccines, Stellar will now ‘move aggressively forward’ with its development of KLH assays and products for immunological use.