The pride and the passion

Aesica Pharmaceuticals has come a long way in just a decade. Hilary Ayshford visited its plant at Queenborough on the Isle of Sheppey, Kent, UK to hear about a major building project and future strategy from Chris Gowland, Group Chief Operating Officer

Aesica negotiated with Abbott to purchase its Queenborough site on the Isle of Sheppey

The Romans knew a thing or two about building and maintaining an empire, so it is appropriate that when Aesica Pharmaceuticals was born in 2004 through a management buyout of BASF’s API manufacturing plant in Cramlington, the company should take on the name of a Roman fort on Hadrian’s Wall. Chris Gowland, Group Chief Operating Officer, is the first to admit that it was not a particularly auspicious time to start up a new company, with the economic recession starting to bite; nevertheless, Aesica has grown every year and now has operations in the UK, Germany and Italy.

The company’s second acquisition was a site purchased from MSD in Ponders End, North London, in 2006. ‘That was a watershed moment,’ Gowland recalls, ‘because we then were manufacturing products for a Big Pharma company. Aesica hadn’t been around very long and said: “sell us your site and we’ll continue to make your products as we have the capability and expertise”.’

The deal with MSD gave Aesica the credibility to negotiate with Abbott to buy the Queenborough site on the Isle of Sheppey less than a year later. ‘Buying this site was a real step-change for us because it brought in formulated products and packaging.’ But although the company could now formulate and manufacture products, it was not able to develop products or formulations for its customers, so in 2010 it bought a small dosage form development company called R5 Pharma that was working out of Biocity Nottingham.

The next acquisition was, Gowland says, a real head-turner: two sites in Germany and one in Italy from UCB. The sites in Monheim and Zwickau in Germany work as a pair: formulation and bulk manufacturing take place at Zwickau, then many of the products are transferred to Monheim for packaging and associated services. The Italian site at Pianezza, near Turin, is standalone and carries out manufacture and packaging of oral solids, oral liquids and terminally sterilised injectables.

Nor is the expansion likely to stop there. ‘We are a full service provider; we have an extensive and flexible range of manufacturing capabilities with a global network of development and manufacturing sites and we are looking to expand,’ Gowland states.

We have got to a size now where we don’t have to buy the first thing that is put on the table; we can look to see if it is a good fit

‘We are looking in Asia and in the US. We have got to a size now where we don’t have to buy the first thing that is put on the table; we can look to see if it is a good fit.’ Any potential acquisition would need to offer something new: a useful geographical location, access to a different market, a new strategic partner or a new technology.

When Aesica took over the site from Abbott in Queenborough its challenge was to fill the spare capacity and to increase the return on assets. ‘The site wouldn’t work for us if all we did was buy it and then just stick with the originator and not fill it,’ Gowland points out. Now there are a dozen different companies putting business through this site creating a balanced portfolio of customer accounts. It is a strategy that is being applied to the sites in Germany and Italy as well, as they had a similar opportunity to improve utilisation at the Queenborough site.

To attract new business the plant has to be upgraded to keep it in line with modern standards. ‘We spend a considerable amount each year in just general capital, looking after things, refreshing, face-lifting and making sure the plant is up to date,’ says Gowland.

To attract new business the plant has to be upgraded in line with modern standards

At Queenborough the packaging area has recently been upgraded, not only to meet GMP standards but also to improve the flow of materials, products and people.

There are, of course, big capital projects as well. In 2011, for example, the company built a facility for manufacturing high potency APIs on a 1–10kg scale at Queenborough, which has subsequently been upgraded to Safebridge Category 3. It has also put high potency capacity into the plant at Cramlington.

Queenborough is in the throes of a major construction project that will result in a new factory dedicated to a single product. As this is a single-customer plant, it is a joint investment backed up by a long-term supply contract.

The original process came into the existing plant as a first step, but now a new building will house up to five production lines, each with a potential output of 500m tablets a year. The new facility will be equipped to handle the API, blend and granulate the formulation, and compress and coat the final solid dosage form. To make the manufacturing process as efficient as possible, the plant will use big bin technology and gravity flow to keep interaction between people and product to a minimum.

‘In years gone by, in terms of where this product is in its lifecycle, it would have been many years down the track before they even considered asking someone else to make that for them,’ Gowland says. ‘That shows the strength of our relationship with the customer; to bring a product in at this point in its lifecycle to a relatively new organisation shows a high degree of confidence.’

Where there has been sad news around closures and consolidation of a number of the Big Pharma facilities, we can help some of those people come back into an operating environment

Commercial production will commence at the new plant in November 2013. With this latest investment and expansion, the facility will have a dedicated workforce of 55 technicians. The facility design will allow the current capacity to be more than doubled in the future, which would require a further 50 staff to be recruited. ‘The idea is that we bring the supervision levels in and get them started on writing some of the procedures, learning the process route and working with the teams that come on site to do the commissioning and the validation of the equipment so that they learn from the start,’ Gowland explains.

‘Where there has been sad news around closures and consolidation of a number of the Big Pharma facilities, we can help some of those people come back into an operating environment,’ says Gowland. ‘So it is a good news story for the local community as well.

‘We have set in place an expansion strategy for continued success. An integral component of this is the provision of strong career opportunities for our highly skilled personnel. We see staff development and business success as working hand in hand. Consequently, we have put in place an internal talent development programme.’

This will be particularly important at Queenborough as the high capacity facility nears completion. ‘Now is the right time because people will grow and learn as the site grows,’ says Gowland.

The packaging area has been upgraded, not only to meet GMP standards but also to improve the flows of materials, products and people

Despite its rapid growth and its comprehensive offering, Aesica wants to be the first CDMO that customers turn to when looking for a full service supplier of APIs and formulated products to the pharma industry. Flexibility is the key to this: whether it is APIs, formulated products, manufacturing for clinical trials or on a commercial scale, liquid or solid dosage forms, technology transfer, steriles, specials, explosive materials, controlled substances or packaging, Aesica aims to use its range of expertise to give its customers peace of mind.

‘To do that, we have values that we try to embed into everything we do; all our employees understand what we are trying to do and how we go about it,’ says Gowland. ‘We are proud and we are passionate. We always try to understand our customers’ needs because there isn’t such a thing as a one-size-fits-all contract manufacturing model.’