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Pharmaceutical Processing News
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Edited by the Processingtalk Editorial
Team on 19 September 2005
Review of Wyeth new Grange Castle
biopharma plant
The new Wyeth plant at Grange Castle in west Dublin is the world's largest biopharmaceutical investment: a report by Gerry Byrne published in Business Plus, Ireland
The new Wyeth plant at Grange Castle in west Dublin is the world's largest biopharmaceutical investment: a report by Gerry Byrne, dating from May 04 It therfore comes as a bit of a surprise to discover that, despite an expenditure of almost Euro2 billion spread over five years, the construction of 21,650 sq m of processing area, thousands more square metres of offices and laboratories, and the combined efforts of some 1,300 people, the weekly output of the Wyeth west Dublin biopharma plant, the world's largest, will barely fill the equivalent of three bags of sugar
That's not all.
The patent on the Wyeth lead product, Enbrel, runs out in 2009 leaving it open to copying by generics manufacturers.
Oh, and did I mention that Wyeth hasn't yet received a production licence from the EU-wide medicines board and is unlikely to be in official production until the middle of next year? If this sounds like a recipe for trouble, Reg Shaw doesn't appear worried.
In fact the man is a testimony for almost Buddha-like relaxed contentment as he works in his airy office overlooking an artificial lake at Grange Castle, Clondalkin.
Shaw, a chemistry graduate of University College Galway, came out of retirement to run the plant after a career running huge chunks of Smith Kline Beecham.
Big blown-up photos of colourful flowers tastefully decorate an entire wall but they are chosen as much for their pharmaceutical significance as their recreational value.
One is the foxglove, traditional source of digitalis, a heart medicine.
Old time apothecaries crushed it to extract the active ingredient to strengthen a weak heartbeat.
But it is much more than a heartbeat away from the way Wyeth now proposes to make arthritic and other drugs at Grange Castle.
It also explains why Shaw looks unruffled about the time it is taking to get into production, and why he doesn't think generics manufacturers are in too much of a hurry to steal his lunch.
Rheumatoid arthritis is a crippling disease caused by a genetic failure of the immune system that attacks and inflames the lubricated cartilage surface of joints.
The body is prompted to send in agents called tumour necrosis factor, which attack the site of the inflammation, but only make things worse.
Eventually the cartilage surfaces become eroded, causing raw bone to grate upon raw bone.
Even slight movement becomes excruciatingly painful and sufferers become bedridden.
Traditional treatments relieve the pain but can do little else.
Etanercept is the active ingredient in Enbrel.
It's a protein and it works by latching onto and immobilising the immune system's foot soldiers as they attack the cartilage.
It's not an outright cure, but it does significantly arrest the debilitating progress of the disease.
But, compared to straightforward 'chemical' drugs, proteins are tricky things to synthesise.
Our bodies, other animals and plants find it dead simple, but doing it in factories is a little harder.
Unless that factory is itself an organism.
That's the approach Wyeth has taken with Enbrel.
In what Shaw believes is the world's largest biopharmaceutical investment, specially bred mammalian cells are grown in stainless steel tanks, fed with nutrients and coaxed into producing Etanercept.
It sounds simple, almost like brewing.
But apart from looking vaguely like a modern brewery, that's where the analogy ends.
There are four incredibly difficult aspects to the process.
Get even one of them slightly wrong and you've lost a complete batch of product worth millions, a whole sugar bag full, perhaps.
This is a high added value product; a year's dose will cost a patient up to Euro10,000.
To be sure they get it right, Wyeth built a three-storey fully functioning scale model of the plant alongside the huge new facility.
Although its annual output would hardly even fill a sachet, it's an accurate version of the full size thing and enables Wyeth scientists to be happy that they're doing things right.
Compared to the hundreds of pharmaceutical preparations on the market, there are only about 40 biopharmaceuticals in production.
"There are high barriers to success, both scientifically and technologically and it's a very expensive technology to undertake.
The skill is to make the product reproducible time after time without any great variation.
Otherwise the regulators will not approve your facility," says Shaw.
Wyeth is currently validating its process with the EMEA, Europe's version of the US Food and Drugs Administration (FDA) and Shaw estimates that the process will take six months.
Although the drug has already got FDA approval, its method of production has not, and Wyeth will have to repeat the process with Washington.
"Barriers to entry are very high.
Even after the patent expires it will be still unique.
Anybody else will have to demonstrate to the regulator that they have a comparable product and we even find that difficult to demonstrate internally, let alone anybody else.
It's very challenging getting into this business.
You might put in a small-scale plant but it would be very expensive to do it on a large scale.
"It's not just a question of sending over a few documents from the US and saying here's the recipe, get on with it.
Even the cell bank we start with has to be handled in a very regulated way.
Scaling up the process is by no means assured.
We will start at a small scale and ramp up to fullscale production under very carefully controlled conditions.
This is a biological system and if it gets infected by bacteria or viruses it can cause the whole process to fail.
We need very clean aseptic conditions," says Shaw.
Five years ago it would have been a safe bet to assume that Wyeth would have gone to Ringaskiddy where Pfizer and other pharmaceutical giants have traditionally located.
So why pick Clondalkin, or even Ireland.
Wyeth has been in Ireland for over 30 years, since it first established a baby food plant in Askeaton, Co Limerick.
Since then other plants have followed and the Irish workforce now exceeds 3,000.
There's a very large pharmaceutical finishing plant in Newbridge employing 1,400 people so the decision to locate this next operation here is not too surprising.
Ringaskiddy, where most of the big pharma operations go, was not an automatic choice, says Shaw.
"We had a number of specific requirements - large quantities of electricity, gas and water, just to name a few, in addition to a skilled workforce.
Believe it or not, getting all of them in one location is not an easy matter.
You might get two out of three, or four out of five but you won't always get them all.
We did a very careful analysis of locations and concluded that all of our requirements were being adequately met here in Clondalkin".
Local authority support is often overlooked by industrialists but Shaw felt that South County Dublin's supportive attitude was also a major driver of the decision to locate in the area.
Shaw was especially impressed with its vision in starting to assemble the vast Grange Castle business park site many years earlier.
"We meet them on a monthly basis and consider what it takes to develop a campus like this.
If we were to do this again we wouldn't dream of going anywhere else.
We are very pleased with the reception from the local authority and the local community".
IDA employment incentives played a very minor role in the decision to locate here although manufacturing tax levels proved a significant incentive, says Shaw.
"Grants were not a function of the decision," he explains.
"It's now very simple and based on the number employed.
Any other diversions in terms of location or training are all gone.
Physical infrastructure, and a skilled workforce, is more crucial.
However a financial incentive like corporation tax is not unimportant.
On an investment of this scale you need to have some return".
And, if they didn't give too much by way of grants, IDA support was important for other reasons.
"It's not easy to work your way through the machinations of telecoms companies.
We enlisted the aid of the IDA to bang a few heads together to solve an absolute mess.
The IDA helped smooth the waters with the ESB too".
Grange Castle is in enterprise minister Mary Harney's constituency and Shaw notes that the Tanaiste has also been very supportive of the project.
Wyeth is pinning much of its worldwide future on the success of the Clondalkin plant and several products still in the development stage, including a children's pneumonia vaccine, are slated to be made there.
The company hopes that biopharmacy will reverse many of the setbacks it has suffered in recent years in more conventional medicine manufacture.
In 2002, Wyeth set aside billions to settle lawsuits after it emerged that people taking a Wyeth diet drug suffered heart damage.
Prempro, one of Wyeth's hormone replacement therapies taken by some eight million menopausal women,was withdrawn in 2002 after clinical trials revealed that, far from reducing the risks of breast cancer and heart disease, it was actually increasing them.
And there's already a website seeking details of people suffering possible Enbrel side effects.
If you suffer from any, the site advocates seeing a solicitor, not a doctor.
Pharmaceuticals are a high risk business with huge rewards for companies that successfully develop blockbuster medicines.
Enbrel is a winner for Wyeth, with sales of $1.6 billion last year up 70% on 2002.
And demand is still growing.
That's why Grange Castle will employ 1,150 people in the biopharmaceutical plant by the end of this year and its ultimate target is 1,300 in direct employment.
Security, cafeteria and other support services may add a further 700 or so to total 2,000 people.
Staffing a venture like the Enbrel plant is not easy.
Two-thirds of the employees will need to be scientifically qualified and Shaw's recruiters have a long shopping list of staff they still need.
Wyeth has managed to source most of the staff in Ireland but the company has still had to recruit specialist scientists from overseas.
In recent years the intake of science students in Irish universities has been declining.
Says Shaw: "This is a worry for us because that will be our life blood going forward.
Normal attrition here will require recruitment of 50 to 100 graduates each year even without expansion.
The total output from the universities is 400 to 500 science-based graduates every year.
It's a worry that youngsters are not focussing on science like they used to".
(Note: This article was first published in the May, 2004 issue of Business Plus, see www.bizplus.ie).
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