An established manufacturer of API products, Dishman Netherlands is in the process of extending its contract research and manufacturing services for third parties. Company CEO Henk Pluim and manager of marketing and sales Evert Drewes brief World Pharmaceutical Frontiers on how it will achieve this through a network of state-of-the-art facilities and further investments in R&D.

Highly potent (HiPo) active pharmaceutical ingredients (APIs) and excipients have long been used by pharmaceutical companies to treat myriad illnesses.

As part of the Dishman Group, a producer of vitamin D analogs and metabolites – which feature in the management of psoriasis, hyperthyroidism and multiple sclerosis – Dishman Netherlands has accumulated an impressive wealth of experience in delivering HiPo solutions to the marketplace.

Focused on small-scale production, ranging from 100mg to 10kg, the company has facilities in the Netherlands, UK, China and Saudi Arabia, allowing for the supply of API in every phase of the drug development process, as well as in-company upscaling and technology transfer.

"High potency has long played an important role for Dishman, albeit on a small scale," says CEO Henk Pluim. "However, there is great synergy between our production facilities across the world; for example, if we develop a product in Switzerland, we can easily transfer it across, on a larger scale, to our operations in India or China."

HiPo and CRAMS

The addition of the HiPo facility in the Netherlands in 2010 was a particularly significant investment for Dishman Netherlands. As well as housing six cleanrooms, three production lines and an irradiation unit for photochemistry, the group recently installed barrier isolation technology in an attempt to bolster its API contract research and manufacturing services (CRAMS) for third parties.

"A large part of our service offering today is CRAM," says Evert Drewes, manager of marketing and sales. "To enable this, we installed a new barrier isolator in our Dutch plant earlier this year. The subsequent advantage has been that we can now work with more unknown substances – where the toxicity profile is unclear and which requires a heightened need to protect employees – as well as other highly toxic materials that need to be contained."

Through this ability to leverage HiPo research services across its network of cutting-edge laboratories, Dishman Netherlands is now in the position to ramp up its value proposition to both pre-existing and potential customers, as Pluim explains.

"We are constantly in discussion with companies that have an interest in new HiPo products," he says. "So they really determine what is possible. Only recently, we signed a contract for new HiPo API development work, which for us is also a nice starting point in making use of the barrier isolator. We are also starting to look into developing further partnerships with companies that currently aren’t part of our client portfolio. We believe we can do this through offering not only traditional CRAMS, but also generic APIs."

Local strengths

Dishman Netherlands has no current plans to expand its production facilities.

"For the time being, we have more than enough space for new API developments and products within our existing laboratories," says Drewes.

However, this doesn’t mean that the company is set to rest on its laurels. While the emphasis on client collaboration is clear, it also maintains continuous dialogue with an extensive local R&D network, set to be further buttressed by future investments aimed at fostering in-house technical talent.

"While we won’t be expanding in terms of production space, we will certainly look to build up our expertise through the teams deployed in the laboratories," says Pluim. "And while we develop all our products in-house, we also have a lot of capability at our fingertips through a network of Dutch R&D companies, which can develop parts on our behalf.

"I would say that the focus of Dishman Netherlands is broadening, not changing. This approach should allow us to serve our customers that are looking to increase their API, but aren’t equipped to meet the development challenges that go with it. This is the niche we are looking to fill."