Biopharma and Vaccines

LEUKOCARE’s patented SPS technology is applied to stabilize biopharmaceutical products and vaccines.

LEUKOCARE’s Stabilizing and Protecting Solutions (SPS) consist of physiological, and non-toxic small molecule ingredients generally recognized as safe (GRAS status), which are individually customized to the specific needs of each substrate or product. SPS is sugar and protein free. SPS serves to stabilize and protect biologics such as proteins or vaccines primarily in dry formulations, bulk or confectioned, intermediate or finished. SPS also enables terminal sterilization of biologics by irradiation or EtO. A Drug Master File is in preparation.

LEUKOCARE’s SPS is typically used as sole excipient during lyophilization or spray drying and gives equal or better results compared to standard sugar based mixtures with respect to protein integrity, aggregation, cake formation, re-dispersion etc. For shelf-life extension it may also be mixed with preexisting formulation components, if necessary. In terminal sterilization scenarios it is highly recommended to use exclusively components from LEUKOCARE’s SPS excipient platform as other components may interfere.

LEUKOCARE develops and optimizes dry formulations for biologics including spray drying, lyophilization, and controlled release formulations involving lipid or polymer vesicles or beads.

SPS is successfully applied to a broad range of different proteins including antibodies (IgM, IgG), enzymes, and growth factors.

LEUKOCARE also has experiences with live virus stabilization, viral vaccine stabilization during thermal stress, and irradiation and / or storage of vaccines.