[Therapeutic antibodies: importance of galenics for efficacy and safety].

Monoclonal antibodies and their derivatives such as antibody fragments, immunoconjugates and Fc fusions, represent the majority of therapeutic proteins in clinical development. Recent successes of such molecules in cancer and in the treatment of autoimmune diseases found a great hope in biotherapeutics. The progress in genetic engineering and in analytical development allowed the production of increasingly humanized antibodies, and thus less immunogenic.

Influence of lipid nanocapsules composition on their aptness to freeze-drying.

Purpose: To link the aptness to freeze-drying and the stability under storage to the topology of lipid nanocapsules.

Methods: The aptness to freeze-drying and the stability under storage of lipid nanocapsules prepared from different compositions with a lecithin content in the 2-20% range were estimated from the preservation of the physical structure, preventing the leakage of the oily phase. The influence of the outer shell composition and of the physical characteristics (investigated by photon correlation spectroscopy and differential scanning calorimetry) on the physical stability was correlated to the topology of the nanoparticulate carrier.