Currently Stellar provides GMP KLH products to the biopharmaceutical and vaccine development markets.
To satisfy the exacting requirements of its vaccine customers Stellar’s manufacturing procedures, have been developed for Good Manufacturing Practices (GMP) compliance, from aquaculture animal husbandry to final protein purification.
- Stellar KLH/ASP - A high molecular weight “native” KLH formulation in ammonium sulfate slurry.
- Stellar KLH/SUBUNIT - A low molecular weight preparation of disassociated KLH “subunits” in salt-free, liquid-stable form ready for conjugation to vaccine antigens. It is extremely pure and homogeneous in size distribution, and rigorously tested for the absence of endotoxin and microbial pathogens. Stellar has filed a Drug Master File (DMF #12135) for this product.
- Stellar KLH/IMG - This is a high molecular weight (native molecule) preparation of KLH in a buffered salt solution. This product is in demand for its superior immunogenicity, and has applications both in conjugate vaccines and as a neoantigen for immune diagnostic testing. Stellar is developing this GMP-grade product.
GMP Grade
Stellar's GMP-grade KLH products are made exclusively from our colony of aquacultured Megathura crenulata using the highest standards of biopharmaceutical processing and quality control.
The KLH protein is a flexible and proven carrier platform for conjugate vaccines in humans. The molecule's potent T-cell dependent antigen presentation properties are matched by compelling safety features, including a lack of toxicity and the absence of TSE (transmissible spongiform encephalopathy) risk.
Environmentally Sound
Stellar's proprietary KLH production processes begin with a patented, non-lethal extraction method for the collection of hemolymph from giant keyhole limpets.
Low Endotoxin
The use of sterile extraction and "clean catch" collection methods result in KLH products with the lowest possible endotoxin and bioburden levels - a significant advantage for immunological testing and vaccine formulation.
Sustainable Supplies
Stellar's sustainable production methods allow hemolymph to be repeatedly harvested from the animals in our aquaculture production colony and minimizes the use of the limited natural population of animals available from the ocean.
Quality Commitment
Stellar’s GMP-grade KLH products are setting new standards for quality and traceability, and are routinely used in the manufacture of clinical trial vaccines and immunotherapies for cancer and other chronic diseases. Our commitment to quality is built into every step of the manufacturing process, from animal husbandry to protein purification to Quality Assurance.
