Stellar Biotechnologies, Inc. has announced that they have entered into an agreement for marketing and sales with SAFC®, a business unit of Sigma-Aldrich a global leader in biopharmaceutical contract manufacturing.
Under the agreement, Stellar will produce KLH commercial intermediate and SAFC will sell, distribute and market cGMP-grade HMW KLH (high molecular weight keyhole limpet hemocyanin) that uses only Stellar aquaculture-derived KLH for applications in therapeutic vaccines.
This collaboration is expected to increase access to a scalable source for KLH, a critical immunostimulatory vaccine carrier protein that will enable the transition from clinical research to commercialization of conjugate vaccine platforms, while managing costs and the risk of supply constraints faced by suppliers that rely on the exploitation of the critically limited natural resource.
Stellar will supply all aquaculture-derived KLH intermediate required for production of SAFC cGMP KLH formulations. SAFC will manufacture HMW KLH under cGMP conditions and provide cGMP clinical and commercial manufacturing of bioconjugation services to support the development and manufacture of conjugate vaccines.
SAFC Director of Business Development Tom Gelineau said, “Our agreement with Stellar Biotechnologies reinforces SAFC’s commitment to providing high quality products and specialized contract manufacturing resources to global biopharmaceutical customers - from research through commercialization.”
Stellar CEO Frank Oakes commented, “The agreement solidifies our position as the only source for a scalable supply of cGMP-grade HMW-KLH for the vaccine business. We have put Stellar’s aquaculture KLH supply front and center in combination with what we believe is the most important manufacturer and marketer of cGMP biologics in the world, Sigma-Aldrich’s SAFC business unit. This exciting development will allow us to move aggressively forward on our diagnostic programs, knowing that the state-of-the-art quality assurance and production capabilities of SAFC will be providing the backbone for companies seeking the highest quality HMW-KLH available for vaccine developers anywhere in the world. We look forward to continuing growth in this relationship and will begin manufacture of SAFC’s initial order as soon as possible.”