Welcome to Eden Biodesign’s latest news round up. With temperatures soaring up and down the country and six weeks of quality time with the kids to look forward to, we thought we’d drop you a line to tell you what’s been happening at Eden Biodesign this last couple of months.

Big Pharmas are continuing to make their mark – snapping up products and companies, particularly close to home (see News in brief below) in the North West! Eden has certainly not been idle either. Staff levels have reached over 30 (tripling in size since December) and two more client projects are underway in the facility.


Novartis expand into North West England
New signs went up in Speke as Novartis take over at Chiron completed. Novartis also offered £310 million for Manchester Biotech Neutech Pharma to get their Mycograb and Aurograb antibody fragment products.

In early June, Novartis, the Swiss pharmaceutical group, announced a £10.50 per share offer for Neutec Pharma, the Manchester–based biotechnology company, reflecting a growing trend between biotechnology groups and big pharmaceutical companies. It also reflects the attraction of Neutec’s late–stage drug portfolio which is in the rare position of having two late stage products which are not licensed to large pharmaceutical companies. Earlier this year, Novartis offered $5.4bn to buy Chiron, the US vaccines group.


Novel targeted approach for prostate cancer tested
The Lancet recently reported that a new, targeted RNA therapy has been shown to be effective in a mouse model of prostate cancer, according to research published online in June’s Nature Biotechnology.

Researchers in the US combined two approaches to create a hybrid drug – a targeting moiety, called an aptamer, and an RNA-silencing moiety, called a small interfering RNA (siRNA). siRNA molecules can silence gene expression but, until now, researchers have had problems delivering them across cell membranes and targeting them to specific cells.

The researchers showed that the molecules effectively mediated tumour regression in a mouse model of prostate cancer and they say that, in the future, they may prove to be useful drugs for treating human prostate cancer and other diseases.


Male infertility and stem cell research
It was reported in the journal Developmental Cell last month that Professor Karim Nayernia and his team of scientists at Georg–August university in Gottingen, Germany have successfully converted embryonic stem cells into viable sperm, capable of fertilising an egg and producing live offspring. If their findings in mice could be extended to humans, it could lead to new treatments for male infertility.

It is illegal to produce human embryonic stem cells in Germany so Professor Nayernia has just moved his research to Newcastle University, to take advantage of Britain’s more liberal regulation of stem cell research.

By contrast, in the US, where Mr Blair is currently trying to broker a peace deal to resolve the conflict between Israel and the Lebanon, American scientists reacted with disappointment earlier this month, at President Bush’s decision to veto bipartisan legislation to ease restrictions on embryonic stem cell research.

The science community in the US are now concerned that stem cell research will fall behind, opening up the fiercely competitive market to countries such as the UK and Korea. Under the bill, stem cell research is only permitted on the estimated 400,000 days–old embryos stored in freezers at fertility clinics that are left over from in vitro fertilisation and would otherwise be discarded.



Apart from the continued influx of new staff, with scientists and operators arriving from Cobra, Astrazeneca, Avecia, Chiron, Medimmune and Abbot, in the last few weeks we have hosted visitors from all over the world. Following Crawford’s successful seminars in Tokyo we received a delegation of five Japanese Pharma representatives for a 3 day visit, with Kassim showing previously hidden talents as a tour guide to the North West. We have also had potential clients visiting from Eastern Europe, Asia, Africa, USA, Continental Europe and of course, our main area of focus, the UK.



One notable British visitor was Sir Gus O’Donnell, Cabinet Secretary and the highest ranking Civil Servant in the Country. The visit was arranged as part of a larger visit to the area but Sir Gus was keen to see the world class facilities at the NBC for himself.

Although we operate the National Biomanufacturing Centre, we are obviously situated in Liverpool – and it’s important to us to build local, as well as national and international links. For this reason we are particularly pleased to announce a new contract with a successful research group within Liverpool University. The first part of the project is helping to produce a monoclonal antibody against a novel cancer antigen.


Technology transfer
Some of the issues that are important in tech transfer at the earliest stages of development of a biopharmaceutical are explained by Richard Dennett, Ph.D., technology transfer manager at Eden Biodesign. See: Genetic Engineering News, vol. 26, No. 11, June 1 2006, www.genengnews.com.

Value can be added by understanding the needs of different kinds of donors or clients. For academic clients, tech transfer to a CMO may be their first contact with industry. ”These people are the powerhouses in generating ideas for new products, but they often don’t really know what tech transfer is,“ explained Dr. Dennett.

Such clients often have an unrealistic sense about the cost and time of bringing products to market and may also lack the traceable records that are needed to satisfy regulatory requirements. Eden works with these clients on areas such as training, due diligence, and filling in gaps to get products and process as watertight as possible.

The SME client, by contrast, has more knowledge and understanding in areas such as quality but may still tend to harbour unrealistic time/cost expectations; meanwhile, a big pharma client tends to know the rules but don’t always get the quality supporting package with protocols and standard operating procedures right, and it may be somewhat risk averse.

For these more advanced clients, it is still crucial to get a thorough understanding of the process and product. Common problems encountered in tech transfer with any type of client include incomplete information, quality issues, and lack of realistic timelines – and these can only be overcome by building good relationships from the start through effective project planning and scheduling of communications.