Stellar Biotechnologies 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.
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.
"KLH is a key component for the success of multiple immunotherapies under development and Stellar is committed to expanding our manufacturing capacity and validating our quality systems as our customers advance toward pivotal Phase 3 clinical studies," said Dr. Baxter.
To produce Stellar KLH, hemocyanin protein is extracted from its native source using Stellar's patented process and then purified and manufactured into various grades and formulations. Due in part to its controlled aquaculture source and manufacturing methods, Stellar KLH has been shown to produce a vigorous primary and secondary immune responses.
