Biological Characterization of Liposomes

Seattle Genova makes use of an extensive variety of strategies for liposome evaluation based on our complete Liposome Platform. Determination of diverse liposome properties are frequently preferred during improvement of a selected product or process. Seattle Genova employs diverse techniques to symbolize the liposome solution and the drug-loaded liposomes. We additionally offer separate offerings on the biological parameters of liposomes characterization.

The biological activities of the components and/or the entire drug product ought to be evaluated where necessary, if the liposome drug merchandise include molecules such as a protein and aptamer, whose conformation performs a vital role in the function of the molecule, as an active substance or a molecule for liposome modification. To carry out a biological assay with a liposome drug product, the reference material for the liposome drug product may also need to be established. To set up the reference material, the manufacturing as well as the analytical procedures and acceptance criteria ought to be provided. To evaluate the stability of the reference material, characterization tests should be appropriately selected, and consistent quality attributes of the reference material throughout the shelf life should be ensured. Biological Characterization parameters are helpful in establishing the safety and suitability of formulation for therapeutic application.

Lists of Biological Parameters

Biological characterization of liposomes consists of three parameters:

• Sterility: Aerobic or anaerobic culture techniques are used to determine sterility of liposomes.

• Pyrogenicity: Limulus Lysate Test (LAL) us used to determine pyrogenicity.

• Animal toxicity: Survival rats, histology and pathology monitored for animal toxicity.