Companies debate cell line R&D needs

Executives of three leading stem cell research companies - Stem Cell Sciences CEO Peter Mountford, ES Cell International (ESI) CEO Robert Klupacs and BresaGen medical director Chris Juttner - have debated the need for new human embryonic stem cell lines and the availability of commercially owned cell lines for basic research.

In a forum at the Stem Cell Summit conference in Melbourne yesterday, all three executives agreed that xeno-free human ES cell lines were critical for the development of therapeutic products, but the number of lines required was at issue.

Klupacs said that he wasn't convinced of the need to have large numbers of human ES cell lines. But Juttner pointed out that there was ample justification to develop human ES cell lines under xeno-free conditions suitable for regulatory approval.

"Later there will be a need for truly GMP cell lines. It needs to be done prospectively," Juttner said.

He advocated the need to remove the "sunset" clause in the pending Commonwealth legislation, which allows for the review of the April 5 2002 cut-off date for embryos used for research, explaining that GMP cell lines would need to be documented from the beginning of the in vitro process.

ESI and BresaGen are two of the companies making cell lines available to researchers in the US, but availability comes at a price. Unencumbered access to ESI's cell lines costs researchers $11,000 and the agreement that cells won't be used for commercial purposes or cloning.

Klupacs admitted that the high cost was difficult for Australian researchers to carry, but said that as a company ESI needed to get some return from their investment in making the cell lines.

BresaGen's Juttner said that the company had a liberal licensing policy with the right of first refusal on IP developed using the cells.

But Mountford said that a cell bank was needed to make human ES cell lines freely available and totally unencumbered for academic research purposes.

He was critical of the commercial control of most ES cell lines, saying that most scientific breakthroughs came from academic researchers, but those scientists were finding it difficult to access the embryonic material to work with.

"Australia has a very real responsibility that it has to take up to make sure academics can get access to embryos," Mountford said.

He said that because the national Centre for Stem Cells and Tissue Repair would be controlled by a commercial entity, he wanted to request that it make cell lines available unencumbered to researchers.

"Peter's concept of a cell bank will happen, probably fairly quickly," said Klupacs in response, adding that it would take time to set one up.