Genetically Engineered Cell Lines: Characterisation and Applications in Toxicity Testing

The Report and Recommendations of ECVAM Workshop 261,2

Reprinted with minor amendments from ATLA 25, 625-639.

Appendix 1

Proposal for a European Repository of Recombinant Cell Systems (EURECS)

The proposed repository could have an autonomous structure or belong to an academic or government institution, such as a university or research centre. A possible alternative name (and abbreviation) for the repository is: "European Repository of Genetically Engineered Cell Lines (ERGENIC)".

Management

The management would have overall control of the repository. It would be responsible for: a) ensuring the quality and stability of the biological materials held in the repository; b) making them available to all users; and c) checking the accuracy of data inserted into the database (see below). The management would be supported by a scientific committee, which would discuss and approve proposed improvements and/or expansions of the system. It would be able to delegate tasks to experts in specific fields.

Since the repository would be a non-profit making organisation, it would need to gain financial support from a variety sources, for example: a) ECVAM and/or other services of the European Commission; b) national centres for the validation of alternative methods (for example, the Netherlands Centre Alternatives to Animal Use, and ZEBET, BgVV, Germany); and c) industrial companies. Some additional support could be derived from sales and the provision of technical services.

Database

A database should be set up for informing potential users on the materials maintained in the repository and on their availability. The database should be readily accessible, that is, provide for a flexible data retrieval system. The structure and content of the database should be devised by a group of experts, paying particular attention to the requirements of users and to the availability of existing databases in the field. For example, data could be collated by collaborating with the European Node of Hybridoma Data Bank, the European Collection of Animal Cell Cultures (ECACC), the European Collection for Biomedical Research, the Microbiological Strain Data Network, and the Catalogue of Cell Lines in Toxicology and Pharmacology (CCLTOP).

The following information on the biological materials should be available: a) identification (name, code, etc.); b) origin (species, strain, sex, tissue, clone, etc.); c) specific function(s) (organ of origin, primary, established, tumour-derived, etc.); d) preservation and culture characteristics (culture medium, serum medium, serum freezing, antibiotics, specific additive(s), split ratio, growth factors, mycoplasma, etc.); e) retrieval sources (references); f) specific function(s) after genetic manipulation (gene expressed, level of expression, polymorphic variants, etc.); and g) constructs and vectors (method of production, characteristics, etc.).

Repository

Cell cultures, microorganisms, vectors, and constructs should be stored in liquid nitrogen tanks safeguarded by appropriate monitoring systems. The repository should carry out basic quality controls to ensure that the material is authentic and free from contamination. If necessary, materials could be returned to the depositor for verification. Biological materials (microorganisms, vectors, cell lines, and constructs) would be made available to all potential users, subject to a number of conditions elaborated by the scientific committee. The precise conditions would differ for users affiliated with non-profit institutions or projects and for users having commercial interests. In the latter case, biological materials would not be offered for sale or used for commercial purposes without the prior agreement of the original depositor. The main conditions envisaged are the following:

  1. The biological material should not be distributed to third parties.
  2. Publications relating to the biological material should refer to the work of the original depositor. No alteration should be made to the original name or code.
  3. Any innovative product or derivative developed from biological material supplied by the repository must be deposited into the collection.
  4. Data derived from the use of repository biological material should be submitted for entry into the repository databank.

The European Repository as an International Depository Authority

To protect an invention on an international basis, the inventor has to secure a patent from: a) a national patent office in a country/state which is party to the appropriate international treaty; or b) a regional patent office, such as the European Patent Office (EPO). Where an invention involves a microorganism or the use of a microorganism, disclosure is not possible in writing; it can only be effected by the deposit of a sample of the microorganism with an appropriate institution.

To avoid the need to deposit a sample in each country in which protection is sought, the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure (the Budapest Treaty; 1) provides that the deposit of a microorganism with any international depository authority suffices for the purposes of patent protection throughout all of the contracting states. A so-called "international depository authority" (IDA) is any scientific institution capable of storing microorganisms which has acquired the status of IDA through the provision, by the contracting state in which it is located, of assurances to the Director General of the World Intellectual Property Organization to the effect that the institution complies with, and will continue to comply with, certain requirements of the Budapest Treaty.

The European Repository could, therefore, seek to become an international deposit authority for genetically engineered cell lines, microorganisms, vectors, and constructs, under the terms and conditions of the Budapest Treaty, by applying to the EPO, or to the patent office of the Member State in which it is located.

Reference

  1. Anon. (1977). Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, ?? pp. Geneva: World Intellectual Property Organization.

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