EAPB at PharmSciFair 2009, Nice, June 8 - 12, 2009
EAPB's contribution to PharmSciFair 2009 is mentioned in EUFEPS newsletter.
PharmSciFair, June 8 - 12, 2009, Nice - report and impression
PharmSciFair is the premier European Platform for Advancing Pharmaceutical Sciences, initiated by EUFEPS taking place in Nice from June 8 - 12, 2009.
EAPB was responsible for the sessions "Biotech derived Products" and "Nano Delivery Systems"
Biotech derived Products
Jan van de Winkel focused in his keynote lecture on Therapeutic Antibodies: trends & future developments: 25% of all drugs in development are presently based on antibodies, 24 mAbs have currently been FDA approved for a wide range of diseases. Improvement of the therapeutic potential goes along with the modification of antibody effector function and the development of novel antibody formats, e.g. fully human therapeutic antibodies derived from human Ig-transgenic mice.
Carina Sonnega reported in the subsequent Minisymposium: Cmc Aspects of First-In-Human (FIH) Studies with Biopharmaceuticals on CMC. She provided an overview of the current global regulatory climate and focussed on particular quality aspects of pharmaceutical products derived from biotechnological processes. This was illustrated with a case study, accompanied by practical hints based on own experience.
Stefan Bassarab concentrated on the aspects of formulation and process development for first-in-human biological products. Predictability for small molecules is generally better than for biologics. The effective strategy for first-in-human formulation goes along with the analytical methods development, standard characterization methods and risk reduction by choice of reliable process equipment.
Key note lecture and minisymposium were well attended. On the ground of excellent lectures, intensive discussions and interactions with the participants followed.
Nano Delivery Systems
Cornelia Keck gave an overview about the physicochemical characterization of nanoparticles, i.e. size, charge and surface hydrophobicity. These characteristics determine the protein adsorption pattern in the body, and therefore e.g. tolerability and organ distribution. Optimized analytical procedures and characterization methods were introduced and evaluated.
Rainer Müller reviewed nanocrystals versus lipid nanoparticles as delivery systems so far accepted at the market. Nanocrystals are the formulation of choice for biotechnological or plant derived molecules being poorly soluble in water or organic media. The lipid nanoparticles are suitable for drugs being lipophilic or soluble in lipophilic media and peptides which can be dissolved in the lipid matrix by solubilisation.
Robert Landsiedel reported about the safety assessment of nanomaterials, toxicity testing and the importance of understanding their uptake and distribution in the body indicating effects of the agglomeration state, surface area and the surface chemistry of uptake, distribution and effects of nanomaterials.
The final EAPB presentation by Cornelia Keck and Rainer Müller presented strategies how to enter the market, using as examples solid lipid nanoparticles and drug nanocrystals. Particularly addressed aspects were intellectual property, transfer to industry, state of excipients, large scale production and first product realization.
All abstracts of the conference you get here (link to www.pharmscifair.org/summer09060812.html).
If you want more detailed information about special EAPB presentations please send your request to managing.director@eapb.org.
The EUFEPS newsletter about the whole conference.
