Peakdale in peak condition

Set in High Peak, contract research company Peakdale Molecular has a customer base that includes GSK, Pfizer and Bayer. Graham Lampard visited the company's new facilities

Arriving at the unmanned and, frankly, derelict Chapel-en-le-Frith railway station contrasted starkly with the clean lines, open space and clinical feel of Peakdale Molecular, just a couple of miles away from the unsignposted station. However, if Arriva North-West had just spent around £3m on its facilities the results would probably be just as impressive.

The new building, which has been designed to a modular concept with the 17 laboratories benefiting from a £100,000 (US$145,000) fit-out and featuring eight fume cupboards in a standard layout, has the capacity for up to 102 scientists with 18 support staff.

Equipment includes a 300MHz nmr, state-of-the-art chromatography and a £500,000m ($720,000) parallel synthesis laboratory. Every lab unit will be staffed by a technical manager, supported by five scientists and will act as an individual business unit, responsible for its own cost base, profits and budgeting. The business units will share administration facilities and costs across the company.

The new parallel synthesis laboratory is used to generate focused libraries of screening compounds for drug discovery. It will also be used to rapidly investigate process parameters in pursuit of route optimisation. The libraries will be based either on customers' templates or Peakdale's own range of novel building blocks.

Multi-compound synthesis can be undertaken on a variety of equipment and using technology capable of both solid and solution phase syntheses. This investment gives the current parallel synthesis team a production capacity of 6,000 compounds or around 40 libraries a year.

new facilities

According to Gareth Jenkins, the business development manager, 'The new facility will enable us to make screening compounds in a highly efficient and cost-effective manner. We offer libraries, on an exclusive or non-exclusive basis, to customers who range from start-up biotech organisations through to pharmaceutical multinationals.

'The emphasis has changed over the past five years or so,' he commented. 'People were bashing out thousands and thousands of similar molecules, calling them a library, and saying: "Look my library's got 5,000 compounds." But because they were all virtually the same, after the 20th negative result, there was no point in doing other 4,000 odd.

'Now, because we try and fit the motif, the library is much smaller, and companies are saving money because they are screening fewer compounds.'

The job of the chemists in the parallel synthesis lab is to come up with a way of designing the 200 or so molecules that represent novel structures to fit the motif within that potential library area. This will be screened against a particular biological test to see whether any structures lead to a new drug discovery programme.

And that is the skill of companies like Peakdale: finding the useful intermediate among a myriad of possible candidates. As Jenkins said: 'It depends on having a good eye for detail, and understanding what the industry is looking for and at.' The chemists need to know where research is taking molecules, he added. through reading journals like J. Med. Chem. they can pick up the vibes of current research, thereby 'joining the dots, making the next logical step and coming up with the key intermediates.'

Peakdale tends to look at the intermediate and then go to the market with it. 'You have to know what the market is,' Jenkins said, 'because you don't want to repeat something that is already out there. So, you are doing a marketing filter, and then the science filter comes in: it's novel, but is it useful? And if the response is right in both cases, then we put out feelers to see if our existing clients would be interested in the intermediate.

'We usually get a quick response, and if they are happy we can consider releasing it worldwide – and watch the enquiries build up over a year or so.'

jointly funded

In addition to the laboratories, the facility comprises offices, meeting and presentation rooms, a despatch room, solvent, hardware and chemical stores, dining area, library and on-line databases.

Jointly funded by profit-generated capital and £1.8m ($2.6m) investment from Close Brothers VCTs, the laboratories will increase Peakdale's capacity significantly, enabling the company to keep pace with global demand for outsourced chemistry services.

Ceo Kimberley Morrison, who has been involved in the pharmaceutical sector since the early 80s, said: 'The new facility marks a significant step towards Peakdale becoming a world leading supplier of integrated chemistry and novel compounds for life science industries. Our customers are already benefiting from Peakdale's philosophy of team-based working, which encourages chemical excellence, commercial awareness and entrepreneurial flair.'

The new site means Peakdale is free of the capacity restrictions that had been holding it back. As Morrison said: 'Following our expansion, we have been successful in gaining two major biotech customers in the UK, and we are looking to move further out across Europe, Japan and into the US.'

Peakdale already has a subsidiary in the US – Peakdale Inc – which is useful, both from the selling and production point of view. 'Americans like dealing with Americans. The US operation provides facilities to break down batches into smaller lots, and having a base there eliminates the problems of time difference.' Peakdale also has contacts with an intermediate company in Japan.

To continue its growth, Peakdale has entered into a risk-sharing agreement with Exchem Organics, designed to aid the drug discovery market through the production of new pharmaceutical candidates. The collaboration could also shorten the time taken from positive identification of biological activity to final, post clinical trial production of a new pharmaceutical.

Under the agreement, Peakdale will design a series of new chemical intermediates from which large numbers of new, drug-like molecules can be produced. By supplying many different versions of these intermediates throughout the pharmaceutical and biotech industries, it is anticipated that new drug candidates will rapidly emerge.

large scale

Where the arrangement is unique is in that Exchem Organics will utilise its large-scale production facilities at Harwich in the UK, to manufacture significant quantities of material before the discovery of any biological activity. This will enable Peakdale to focus on disseminating these intermediates quickly throughout the industry, generating leads at a far earlier stage than would normally be the case.

As the emerging drugs progress through clinical trials and beyond, Exchem will be able to meet the demand for the new intermediates, considerably shortening normal outsourcing timescales.

'We are looking to collaborate with companies,' said Morrison. 'We can go up to a maximum of about 10kg here, but that has to be done in lots of individual batches. There are a number of products that we want to commercialise, and Exchem is going to make them beyond the 10kg scale. We will sell the small quantities and they will sell the larger volume.'

On whether this was to the first of a number of collaborations, Morrison commented: 'We are in conversation with a number of companies. We now have the space and capacity to expand in this area and move the company forward.

'Some of the mid-scale manufacturers are looking for the kind of expertise we have in terms of generating new and interesting molecules, so it works both ways.'

scale-up production

'What is exciting about the Exchem venture is that in the past, we produced the intermediate to the kilo scale, but our global customers are wanting multi-kilo, possibly hundreds of kilo quantities. In the past we didn't know who to go to, but we couldn't do it ourselves, so it was a case of selling the process or the chemistry and moving on,' said Jenkins.

'Now, it's an option for us to take it to the next stage,' interjected Morrison. Exchem is also prepared to put some investment into the next stage. 'It is prepared to look at our skills of spotting the next good intermediate and to say "Yes, we'll put a little bit of investment into that", and look to realise that in a year or two's time,' said Jenkins.

With the appointment of Morrison and Jenkins it seems that Peakdale is intent on continuing its dramatic growth. Dr Ray Fisher, founder and chairman of the company, commented: 'Their appointments play a significant role in the continual development of the firm and further enhance our aim to become the world's leading supplier of integrated chemistry and novel compounds for the life science industries.'

Peakdale's main aim for next year is also to raise its profile. 'People were saying they had never heard of us before – but it was intentional. Now, we have to make that step change from being deliberately quiet because we didn't want to turn customers away [due to lack of capacity], to making more of a noise and convincing them that we have something valuable to offer,' said Morrison.