PARIS ¿ Clean Cells SA, a biotech start-up specialized in the culture and analysis of stem cells, is seeking FFr3 million to FFr5 million (US$395,000 to US$660,000) from venture capitalists and other investors to enable it to further expand its laboratory facilities.

Based in Nantes, Clean Cells was founded in July 2000 by four researchers, three of whom were cellular biologists working for the French National Institute of Health and Medical Research (INSERM). It started with seed capital of FFr2 million provided by its founders and other individuals.

The company¿s marketing manager, Bernard Geerens, told BioWorld International that it invested FFr500,000 of that in the installation of a bacteriology laboratory complying with FDA and European pharmacopeia norms, which is now operational. It plans to start talking to potential new investors in September and hopes to complete the funding round within six months, he said.

Clean Cells is mainly engaged in fee-for-service activities, which means that ¿it has revenues,¿ as Geerens put it. It provides public and private laboratories engaged in the cultivation of both human and animal cells a variety of testing and analytical services to ensure the integrity of their raw material. It claims to cater to a growing need in the pharmaceutical industry, insofar as it is increasingly replacing animal testing by other methods, such as cell culture.

The main services provided by Clean Cells are the detection and identification of mycoplasma in cells and the decontamination of mycoplasma ¿ infected cells. Its other activities include cellular quarantining, cryogenic conservation of decontaminated cells, and cell production and characterization. The company points out that an estimated 40 percent to 60 percent of cultured cells suffer from mycoplasma infection, and that seven types of mycoplasma account for 95 percent of that contamination.

Mycoplasma are small bacteria that have no outer walls and are invisible to the naked eye. They are a serious problem because they modify cell function, creating problems of protein synthesis and cell division and growth, and because they damage the membrane, undermining its integrity, altering exchanges between cells, and modifying internal secretion stimulation. They also cause chromosomal aberrations, adulterated histones and apoptosis triggering.

Clean Cells has a variety of methods for detecting mycoplasma, including both direct and indirect testing of the cells and PCR-based tests. It also has developed its own technology for decontaminating infected cell cultures, which is nontoxic for the cells. In addition, it cultures cells under contract for third parties, which are produced to GMP standards and are guaranteed free of contamination. On the strength of this expertise, the company also provides training in areas such as good cell culture practice, quality assurance and regulatory requirements.

Geerens stressed the importance of having the capability to perform the tests and controls required by the FDA in the U.S. He said he hopes that the revised bioethics legislation being drafted by the French government, which encompasses controversial issues such as therapeutic cloning and human embryo research in its broad scope and is due to be debated in Parliament next January, will introduce compulsory cell testing by third parties. In that event, said Geerens, Clean Cells would have the field to itself to start with, since it does not have any competition at present. But he acknowledged that such a development, especially if it took place at a European level, would undoubtedly attract some of the many American companies with the same expertise into the market.

Clean Cells also is engaged in three research and development projects in the field of cellular biology. One, which Geerens described as ¿confidential¿ for the time being, is for the development of a cell therapy for what he described as a ¿much-feared virus.¿ It is an international collaboration, and Geerens said Clean Cells¿ strategy was to take the product at least as far as Phase II clinical trials.

The two others are both in the agro-food area and are being undertaken on behalf of third parties. One entails the search for mycoplasma and other contaminants in a foodstuff, while the other calls for the phenotyping of a species of duck to determine those that will produce the best and largest fattened livers (foie gras), a highly prized delicacy in France.

The funds Clean Cells is hoping to raise are required for the construction of another building to house more laboratory space, said Geerens. But he said the company could get by without the support of venture capitalists, since some of the industrial partners and academic institutions with which it collaborates might be persuaded to invest in the company. Be that as it may, he said it probably would not need a second funding round, since ¿we could be profitable pretty quickly if all goes well.¿

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