Liposome Formulations siRNA Liposome Preclinical Drug Development

By: Northern Lipids  09-12-2011

NLI provides a range of pre-formulation services to support characterization of Active Pharmaceutical Ingredients (APIs). These include physical characterization, forced degradation, and excipient compatibility studies.Our formulation experience extends to the development of micelle, emulsion and liposome formulations of a diverse range of compounds, including small molecules, peptides, proteins, nucleic acids, antisense and siRNA. Programs involve identification of a suitable manufacturing process, characterization of the formulation, and preparation of several candidate formulations that differ in lipid composition, drug/lipid ratio, particle size, and manufacturing strategy. The formulations are screened using a variety of in vitro tests designed to identify the most promising candidates, and ascertain whether the formulations have relevant pharmaceutical properties (chemical and physical stability, controlled drug release). Selected formulations are studied using in vivo models, to determine pharmacokinetic and pharmacodynamic properties. On the basis of these programs, our clients are positioned to identify a lead candidate for further pre-clinical testing.

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GMP Manufacturing Facility, cGMP Formulation Development

The route for final products is separated from incoming goods and final product is stored in a designated area while awaiting shipment.The facility is also equipped with a cold storage, back-up generator, purified water distribution loop, WFI reservoirs, Glycol heating system, HVAC, Clean compressed air & bottled gases.