Even the largest names in pharmaceuticals need some help from their friends from time to time, as Alan Swaby learns in discussion with Penn Pharma.
A career in pharmaceutical R&D is not for those with a short attention span. Perhaps growing bonsai needs more patience; but the painstaking search for new drugs can’t be far behind. Even when an exciting breakthrough is made in the form of a promising new molecule, the hard grind has barely begun.
But this all bodes well for Penn Pharma. Its raison d’être is to take over the D in R&D. In the business for over 30 years, it’s now one of the longest established pharmaceutical services companies around. From its UK facilities in Tredegar, South Wales, it works with members of the international healthcare industry, providing pharmaceutical companies of all sizes with drug development, clinical trial supply and manufacturing services.
“It’s a hackneyed cliché, I know,” says finance director Lee Mainwaring, “but we actually do provide the proverbial one-stop service. Not only that, but we have something to offer everyone, from the entrepreneurial sole scientist who has discovered a promising molecule to multinational household names.”
In case you’re wondering, Penn is not named after the founder of the business but the village in Buckinghamshire where it started in 1979. In 1986 it was attracted to Wales by the Welsh Development Agency and has flourished there ever since. South East Wales has a good pool of skilled workers and the universities of Cardiff, Swansea and Bristol are in close proximity when it comes to recruiting highly qualified staff, especially forensic and analytical science graduates.
“The sheer variety of work we do,” says Mainwaring, “gives young scientists accelerated experience. The average length of service with Penn is six years and then staff are ready to move on and up the career ladder which may be into our internal project management group or move externally. This we don’t mind because it is good for all organisations to be refreshed with new blood.”
Interestingly, at board level, Penn Pharmaceuticals has done just that. Over the years it has transferred ownership via management buyouts on three occasions—the most recent was a £67 million purchase three years ago. With backing from LDC Private Equity, the new management team has the funds and the strategic intent to finance a £12 million development programme which will be assisted by the Wesh Assembly Government. The plan is to create new facilities which are expected to more than double the current turnover of £30 million within the next few years.
“One part of the service which has attracted considerable attention,” says Mainwaring, “is our ability to work with small, highly potent compounds which need much more careful handling. This is a growth area we have identified and we are planning additional containment suites to accommodate this type of work.” Furthermore the recent investment in Xcelodose equipment will enable the efficient processing of the small amounts of active pharmaceutical ingredient that is required to be dispensed. This is very important for potent drugs.
Take a tour around Penn’s facilities and in addition to two low humidity clean rooms, for the more routine work there are 16 class 100,000 cGMP (good manufacturing practice) manufacturing rooms and eight GMP secondary packing rooms. Then, for the more potent drugs, there are two level 3 containment rooms plus a level 4 high containment suite, where work is carried out with the molecules safely in a closed process train utilising split butterfly valves, glove boxes and, for additional safety, operators in protective suits.
On the other side of the building Penn has all the requirements needed to turn molecules into medicines: mixers, driers and tablet presses that can supply the full gamut of bottling, sealing and packaging equipment to make compounds ready for the market.
Penn has over 150 clients on its books made up from SMEs which have precious little in the way of facilities and which rely on Penn for virtually all their development work, through to the multinational majors. With the former, the recession and availability of development funds from financial institutions has held work back but after a relatively flat period, activity is once again picking up and the last six months have shown a 30 per cent increase in Penn’s core business.
For the latter, it’s not so much the facilities that are attractive as the speed at which the work is progressed. “Our Fast Track service, for example,” says Mainwaring, “is proving beneficial for pharma companies involved with clinical trials. It’s a logistical service getting product in the specified manner to clinical researchers who are conducting the clinical trials. We prepare, package and distribute the drug under investigation along with placebo which can include complex double blinded trials much quicker than would normally be the case. Dedicated teams can prepare, pack and despatch product through in days, rather than the weeks it would normally take.”
Penn also finds that it is a popular portal for drug companies from outside the EU wishing to enter the European market. Legislation determines that someone designated a Qualified Person and usually trained to PhD level must supervise any such approach. US and Japanese pharmaceutical companies often call on Penn, which currently has five QPs on staff.
At the other end of the spectrum is the work Penn does for the NHS on what are known as ‘specials’—unlicensed medicines. Ironically, manufacturers need to hold a licence to manufacture unlicensed products in MHRA approved facilities. These medicines are made from active ingredients bought from GMP sources and subjected to full analytical testing before use in just the same way licensed drugs are made. They might involve a different formulation—a liquid, for example, where tablets can’t be swallowed—but they can only be supplied against bona fide orders from registered wholesalers, pharmacies, dispensing doctors and hospitals to satisfy named patient prescriptions.
On the production side, Penn has borrowed from the wider manufacturing world and has an online portal through which clients can see the status of inventories being held, or the progress of a new batch of medicines being prepared. “But rather than producing Just in Time,” says Mainwaring, “we try to ensure adequate stocks are always on hand Just in Case.” After all, the one area where patients would be in short supply is when a sick person can’t get access to the medicines needed. Penn is ultimately here to serve its clients and improve the quality of life for all who require medicinal products. www.pennpharm.co.uk
