Collaboration of drug developers and manufacturers
The second edition of this year’s Biomanufacturing Symposium on 7th October 2009 at BIOTECHNICA in Hannover (Germany), offers an ideal exchange platform for biopharma drug developers and manufacturers. This one-day event jointly organised by Capgemini Consulting and Deutsche Messe will address current topics of the biomanufacturing industry in three sessions and two panel discussions. Leading experts in the field, Prof. Dr. Rolf Werner, Boehringer Ingelheim GmbH and Dr. Klaus Schoepe, Rentschler Biotechnologie GmbH will discuss trends and solutions with the speakers.
This year’s focus will cover the following topics: collaboration strategies of drug developers and manufacturers, particularities in biosimilars process development, and the importance of process validation in the early stages of development.
This session will highlight important co-operation strategies, like fee for service, licensing, or risk sharing in process development, addressed from both sides – developers and manufacturers of bio-pharmaceuticals. To what extent is manufacturing know-how a prerequisite for successful technology transfer? How to secure successful process development and manufacturing? Three experts will join forces to answer these and other questions: Dr. Timo May of Richter-Helm BioLogics GmbH & Co. KG, Dr. Klaus Drexler of MediGene AG and Dr. Dirk Pelster of TRION Pharma GmbH.
Biosimilars development cannot be seen equally to the development of generics – neither from a process development nor from a regulatory perspective. Imitator drugs of the biopharmaceutical industry are bound to restrictive regulatory requirements and therefore challenge the process development of biosimlar companies. Dr. Herrmann Allgaier of Merckle Biotec GmbH will talk about paradigm shifts in biosimlar development and production. Dr. Katrin Buss of the Federal Institute for Drugs and Medical Products will present the regulatory background of biosimilar development in Europe.
The early identification and capture of relevant process parameters in biopharmaceutical process development and accompanying changes in the regulatory framework are intensively discussed within the industry. Topics of this session will be among others reproducibility exercises, optimisation of process steps through ‘Design of Experiment’ (DoE) and the integration of ‘Process Analytics Technologies’ (PAT) in process development. Dr. Felix Oehme of Bayer Schering Pharma AG and Markus Hofbauer of Wacker Biotech GmbH will present and discuss their views and recommendations.
The Biomanufacturing Symposium will take place in the Convention Center (CC), Hall 3B, at the Hannover Exhibition Grounds on 7 October (11.30 a.m. to 6.00 p.m.)
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