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ACTIP position paper on future areas of research to be funded

Rotterdam, September 1997

The Animal Cell Technology Industrial Platform (ACTIP) has identified a number of areas within the field of animal cell technology, but also in fields closely related, where it believes that funding by the EU will be most effective. It has the conviction that this funding will create the opportunity for the European industry active in this field to improve its competitiveness, the employment and its growth in a global market. Funding of these topics will also stimulate basic research and serve to establish new networks among European scientists. It will reinforce contacts between the research based industry and academic research in a European context. Finally, we believe that a dynamic and blossoming academic scientific community is a prerequisite to the further development of the innovative research-based industry. We believe in this context that, regarding animal cell technology, more stimulation should be given to fundamental cell biology, with emphasis on those aspects that can be considered cutting edge.

Production of Proteins by Animal Cells

Although a number of products are being made with the help of animal cells, the processes employed can still be considered as relatively inefficient. Also, some potentially interesting products are extremely difficult to obtain in sufficient quantities to permit their clinical use. We would suggest the following projects focussed on the cell, the process and the product. The cell: Metabolic-pathway engineering, in order to improve cell productivity and behaviour under processing conditions; Identification of the bottlenecks in cellular secretion pathways, followed by the removal of their effects by engineering of the host cell; Further improvement of expression systems, taking into account robustness, long term stability etc; Isolation or induction of differentiated cell lines having the potential to be cultured at large scale. The cell lines will be used for the production of new substances difficult to obtain otherwise; The process: Development of improved measurement and control methodologies, in order to get a better understanding of production processes. The increased knowledge of the cellular metabolism so obtainable will give the opportunity to increase production yields and product consistancy; Development of novel bioseparation systems, leading to simpler and more cost effective production processes; The product: Studies on protein products to analyze the in vivo function of post translational modification, including N and O linked glycosylation. The studies will result in a more reasoned choice between production processes (prokaryotes-eukaryotes) and, in respect of glycosylation, give valuable/essential information on the kind of 'glyco-engineering' required.

Gene and Cell Therapy

It is expected that gene therapy will eventually lead to the availability of a whole new class of therapeutics. However, considerable hurdles will still have to be overcome. We believe that within the Vth Framework Programme, attention should be paid to the following points, understanding that the biosafety aspects should be an essential element of every project: Further development of cell mediated gene transfer; Development of target specific vectors, permitting the gene delivery to specific cells or organs; Development of cell, tissue or organ specific expression systems; Development of cell lines that do not induce immune responses in the host and that are safe to use.

Novel Vaccination Methods

Continuous focus on basic research to elucidate the mechanism of the immune response, and on development of novel vaccination methods, will be of great importance to public health. It will also be of importance that Europe takes here a leading position in order to safeguard the present strong position of the European vaccine industry. Attention should be given to: DNA vaccination for both human and veterinary purposes with special attention to: The influence of the route of administration on the prevention of infection (vaccination); Optimization of the in vivo transfer of DNA to the target tissue; The optimization of the expression level of the vaccinating antigen in the target tissue; The search for effective 'genetic adjuvants' by the coexpression of other genes (like chemokines or cytokines); The biosafety aspects; Ways to produce native and stable proteins. Solve the downstream processing problems of particle-like proteins. Development of methods permitting the cryopreservation of very large numbers of animal cells. This will give the vaccine industry the posibility to face sudden demands for very important quantities of vaccines, i.e. in case of epidemics.

Other DNA Therapies

The field of gene transfer by the direct injection of DNA coding for therapeutic proteins can be considered as being on the borderline of gene therapy and nucleic acid vaccination. This area will require much attention since it might be in some cases an alternative to the treatment by recombinant proteins. Special attention should be paid to: The route of administation; Expression levels in target tissues and their control; The study of potential immunological reaction to the transfected cells; The biosafety aspects.

Use of cells in the drug discovery process

Further development and miniaturization of cell-based drug screening systems, including the preparation of cell substrates; Research aimed at the partial replacement of pre-clinical phases in drug development by in vitro methods; Further development of In vitro toxicology;

Other Areas and Activities

Other areas for which ACTIP believes that EU funding will have an important positive impact on the competitive situation of the European industry include: Studies leading to the development of artificial organs, e.g. liver, pancreas etc.; Continuation of the EU's efforts to give unbiased information on biotechnology to the general public in order to improve the public perception of this important field. An increase in the patent awareness among European scientists. Courses on the protection of intellectual property should be an integral part of the scientific curriculum.

Conclusion

ACTIP is convinced that allocation of resources in the identified areas will broaden the fundamental basis of knowledge in biotechnology and subsequently will lead to further impulses of innovation for the benefit of mankind and the environment. This future research will contribute to the development of new medicines and the relief of human and animal suffering. Rotterdam, September 1997

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