Liposome based technologies
We are a leader in lipid nanoparticle-based drug delivery systems, with an attractive combination of specialized skills and cutting-edge infrastructure.
Specifically, liposomes are spherical vesicles with one or more lipid bilayers that surround a payload (the drug substance). They can be employed to control biodistribution and reduce side effects. We have extensive experience in this field, and offer a range of liposomal formation and drying technologies. In addition, we can assist with aseptic powder filling, API sterilization by crystallization, and handling high-potency compounds.
Our formulation development capabilities include pre-formulation studies for the assessment of API and excipient compatibility. We develop and screen formulation prototypes to select suitable candidates and manufacturing processes. In later stages, we can assist with scale-up, and prepare test batches for GLP toxicology studies. In line with the FDA’s draft guidance on liposomal drug production, product performance is assessed using diverse physical-chemical measurements – such as particle size distribution, in-vitro release analysis, encapsulation versus free-drug quantitation, and drug-to-carrier ratios. These enable the development and optimization of new formulations with specific characteristics.
We support GMP manufacturing and have cleanrooms and equipment designed for manufacturing lipid and other nanoparticles. Specifically, we assist with the production of:
formulations containing oligonucleotides
sparingly soluble compounds
and HPAPIs - from sourcing raw materials, to compounding and filling, release testing and transfer to commercial manufacturing facilities.
Moreover, we offer analytical tech transfer, assay development, and method qualification and validation. We also perform cGMP release and ICH stability testing – giving our customers a key advantage when it comes to taking high-quality formulations from the lab bench to the bedside.