Stellar Biotechnologies, a leading manufacturer of a key protein utilized in multiple immunotherapy development pipelines targeting Alzheimer’s, lupus and cancer, among other diseases, announced that third-party trial results have demonstrated that the company’s KLH manufacturing methods achieve robust viral clearance.
This clearance step is a key quality assurance milestone under Stellar’s initiatives to increase the scalability and throughput capacity of its manufacturing processes.
Results from testing completed by Texcell, a contract testing organization for viral safety, demonstrated that Stellar’s manufacturing process for its most widely used formulation effectively removes three representative viruses, and meets suggested regulatory criteria for robustness. While routine quality testing has never detected the presence of viruses in Stellar KLH, one of the principal approaches to control the potential presence of viruses in biological products is to purposely introduce viruses in a test environment and demonstrate the capacity of the production process to remove them.
Stellar Executive Vice President of Corporate Development, Gregory T. Baxter, PhD, said that the company aims to roll out manufacturing optimizations ahead of the next phase of its customers’ clinical studies, and will continue to routinely test for viruses and validate the viral removal of its manufacturing processes as needed.
Based north of Los Angeles, USA, Stellar Biotechnologies is the leader in sustainable manufacture of Keyhole Limpet Hemocyanin (KLH), an important immune-stimulating protein used in wide-ranging therapeutic and diagnostic markets. KLH is both a key pharmaceutical ingredient in many new immunotherapies (targeting cancer, immune disorders, Alzheimer’s and inflammatory diseases) as well as a finished product for measuring immune status. Stellar is unique in its proprietary methods, facilities, and KLH technology. The company is committed to meeting the growing demand for commercial-scale supplies of GMP grade KLH, ensuring environmentally sound KLH production, and developing KLH-based active immunotherapies.