ADVANCES IN CELL CULTURE FOR CLINIC
AND PHARMACEUTICAL INDUSTRY

Tentative Program, May 17 - May 18, 2010

Course Description
The culture and expansion of cells is one of the basic methodologies in immunological, biomedical and biotechnological sciences. The emerge of a greater interest in biotechnology and its products for diagnostic and therapeutic approaches in the last 10-20 years has also stimulated the improvement and extension of methodology for large scale handling and expansion of animal and human cells, stem cells and tissues as well as other cells.
Implementation of bioreactors, needed for medium scale and large (industrial) scale in vitro production and purification of cellular proteins, enables the production of larger amounts of well-defined cell derived proteins such as monoclonal antibodies for diagnostic and clinical use.
Optimisation of productivity requires a better understanding of cell physiology, apoptosis, growth-factors and culture media composition, especially in high cell density cultures: hydrodynamics, oxigen and/or shear stress and differences between different types of bioreactors. Information on glycosylation patterns is also important since these can have great impact especially on in vivo efficacy in therapeutic schemes. Also here the differences in type of bioreactor may be important.
PAT, high-throughput screening, scale-up, scale-down and other bioprocess related issues no longer are a trend, but a must. Whether it is for micro-bioreactors, lab-scale autoclavable systems or for S.I.P./C.I.P. bioreactors , it is a fact that advanced measurement and control units as well as SCADA are to be installed.

Classical monoclonal antibodies and constructs, humanized antibodies, bi-specific antibodies, conjugates and possibly single-chain antibodies will therefore also play a major role, especially for products aiming at commercial (and) or clinical applications. Apart from diagnostic kits, some interesting areas are: purging of bone marrow for transplantation, cardiovascular diseases, rheumatology, tumour therapy and treatment of septic shock.
Blood transfusion was the first commonly accepted cell transfer procedure for men, followed by organ transplantation and bone marrow and, more recently, stem cell transplantation. Specialized equipment for the separation of cells and cell products has been developed for (blood)transfusion, BMT, immunotherapy, somatic cell-therapy or the production of hormones and cytokines. Aiming in vivo administration in man, cells and products have to be prepared at strictly defined conditions: Good Manufacturing Practices (GMP). Quality assurance, process control, validation and quality control are inevitable for instance for “therapeutic antibodies” and vaccines.
This course will focus on theoretical and practical, operational aspects, implementation of methodological and technical aspects, as well as on regulatory requirements and facilities for large scale expansion of cells (fermentation) and purification (down stream processing) of cell products for medical use. Hands-on as well as video demonstrations and excursions will be included. The pro’s and contra’s of the various methods will be discussed. In addition an update will be given of recent developments and (clinical) applications of, humanized therapeutic antibodies, recombinant proteins, gene therapy and stem cell therapy.

Who Should Attend
Participation to the course is aimed at postgraduate junior and senior scientist, (M.D., Ph.D. or Engineers in live sciences such as cell biology, immunology, medicine and biotechnology, involved in development and/or up-scaling/fermentation or purification of biotechnological products.
R&D and production managers with an multidiscipline interest who wish to broaden their scope and/or to update their knowledge on recent advances and prospects will also benefit from participation to this course

Course Director
Rene J. van de Griend Ph.D. Qualified in cell biology and medical immunology. In 1976 he started his research career at the Central Laboratory of the Red Cross Blood Transfusion Service in Amsterdam. He gained a Ph.D. in 1981 from the faculty of medicine, University of Amsterdam. Thereafter he was employed as Immunologist at the Dr.Daniel den Hoed Cancer Center in Rotterdam for the development and implementation of immunotherapy protocols. He is an experienced scientist in cell biology and immunology and has published over 75 scientific papers. In 1987 he joined Centocor Europe in Leiden, The Netherlands to manage and starting up R&D fermentation projects for production of Mab’s at pilot and industrial scale. At present, as managing director of BIOCULT bv (www.biocult.com), he is involved in up-scaling (contract production) of cell derived proteins, especially monoclonal antibodies in Leiden, The Netherlands. BIOCULT is NEN-EN-ISO-9001:2008 certified and in addition

Tel: 31-71-5215443
e-mail: Biocult@sandtcourses.nl www.SandTcourses.nl