Characterizing liposome products reinforce quality control, which can ensure reproducibility. Assessment of liposome critical quality attributes (CQAs), such as physicochemical properties, composition, encapsulation efficiency and drug release from liposome preparations, and establishing drug product specifications are all crucial for drug development. Our Analytical and QC scientists bring deep technical expertise, extensive experience, and access to state-of-the-art instrumentation in both R&D and cGMP settings. They perform method development and validation, cGMP testing and release, as well as stability studies for in-process and finished products. 

With over years of experience, Our scientists have extensive expertise in liposome research. Our scientists take pride in delivering top-notch liposome products and services through our advanced platform. We offer characterizations including morphology (i.e., shape), particle size, distribution, zeta potential, encapsulation efficiency (EE), and drug loading (DL) for fundamental analysis of the physicochemical properties of liposomes.

Liposome performance is significantly influenced by their chemical and physical characteristics. The morphology (such as spheres, rods, worms, and disks) determines the surface-to-volume ratio, which influences their blood circulation time and targeting capability. Furthermore, the drug loading and particle size of liposomes are the most significant variables influencing the pharmacokinetic and pharmacodynamic characteristics of drugs. To ensure the stability of liposome systems, zeta potential and polymer dispersity index (PDI) measurements are commonly used. By avoiding the toxicity associated with surface charge, a specific zeta potential can enhance the biocompatibility of liposomal delivery systems. PDI is a dimensionless value from 0 to 1 that reflects the width of the particle size distribution. The smaller the PDI, the more uniform the liposome size is. Therefore, precise and efficient measurement of liposome properties is essential for the development of novel and effective drug delivery systems.

Formulation Characterization

•Particle size (Brookhaven 90Plus part of ZetaPALS)

•Zeta Potential and Mobility (Brookhaven ZetaPALS, qNano)

Particle size distribution (qNano, Brookhaven ZetaPALS)

•Drug encapsulation efficiency (various approaches)

•Microscope examinations (uniformity, drug crystals, centrifugation)

•Particle shape, lamellarity and particle Sub-structure (cryo-TEM, FF-EM)

•Phase transition, enthalpy of lipids and liposomes, protein denaturation temperatures (MicroCal VP-DSC) 

•Polymer glass transition, melting point (Perkin Elmer DSC 7)

•Lyophilization/Freeze trying (liposomes, peptide/proteins, Virtis Genesis 35EL with stoppering)

Formulation analytics

•HPLC method development 

•HPLC measurement of drug potency and degradients

•Lipid concentration assay

•Formulation stability (chemical and physical)

•In vitro drug release assay

•pH

•Osmolality (Wescor Vapor Pressure Osmometer 5520)

•Refractive Index