The benefits of late-stage customisation for orphan drug manufacturing

It is estimated that 25-30 million people are impacted by rare diseases which require orphan drug treatment across Europe. These are patients with conditions which impact one or fewer people per 2000, such as Crohn’s disease or neurofibromatosis.

Orphan drugs, synthetic pharmaceuticals intended to treat very rare diseases, are a high cost/low demand products. This means they aren’t developed by the pharmaceutical industry on a very large scale.

With an increasing number of biopharma companies developing orphan drugs and launching them onto the EU marketplace, pharma biotech CDMO Almac has sought out an innovative way of providing late stage customisation to these products.

Across Europe, consumers tend to favour the use of blister backs for solid medications, as opposed to bottles of pills which are more prevalent in the US. A significant part of Almac’s oral solid dose commercial packaging business therefore centres around packaging tablets and capsules into blisters, which need to be distributed to multiple European states from a single batch of medication.

Utilising the Hapa Blisterjet printer, Almac is able to maximise the stock flexibility of its clients’ valuable orphan drug products, meaning they can distribute product more efficiently between different European countries.

The Blisterjet allows for drugs to be produced as brite stock, a full batch of active product in blank blister packaging. The system uses drop-on-demand technology to print the sealed blank blisters with the country-specific information needed, meeting the late stage customisation needs of Almac’s orphan drug production.

Almac Head of Production Philip Lightowler said: “The technology attracts new business, with clients appreciating the supply chain flexibility and enabling the operational teams to improve blister pack efficiencies with reduced changeover events.

Regulatory requirements mean that drug product packaging must be in the dominant language of the country of distribution. Plus, patient numbers can vary hugely from state to state – thalassemia, a genetic form of anaemia, is rare in Northern Europe but quite common in the Mediterranean. Therefore, producing vast amounts of pre-printed blister lidding in multiple languages to allow for distribution to multiple European markets, when the demand in many of these markets is as low as a few hundred units, is neither efficient nor cost-effective.

The single-colour, fully digital, ultra violet piezo inkjet printing system of the Hapa Blisterjet can be used to print both blank and labelled blisters, eliminating the need to establish entire blister lines for each region.

This helps to improve the efficiency and capacity of the line. It is no longer necessary to establish an entire production line for each product variant, eliminating the need to amass various inventories of printed materials and finished goods. The Hapa Blisterjet instead allows for one batch of drugs to be customised for as many as five different markets at once.

The printer is also capable of printing on multiple materials, from Tyvek and PVC to aluminium and paper-backed foil. The system is available for inline or near-to-inline configurations, and allows for leaner logistics, reduction of waste, and the highest print quality possible for serialisation, randomising, and codes.

Almac has found the use of the Hapa Blisterjet hugely beneficial for both its business and its clients, and has been using the printer in its UK-based commercial packaging facilities for over four years. The company has recently purchased a further Blisterjet printer for its new European commercial packaging facility, indicating its satisfaction with the investment.

“When we were reviewing suppliers against our definitive user requirement specifications, it became clear that Hapa was the industry leader in this area and the only company that could provide the technology and experience to meet all our needs,” Lightowler said. “We would certainly consider Hapa to be at the forefront of printing technologies and certainly within the blister pack inline and or offline printing arena.”

Hapa is a leading supplier of inline printing systems for pharmaceutical packaging, with partners using its technology across the globe. Founded in 1933, the company currently has more than 10,000 of its systems installed and operational worldwide.

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture, packaging and drug product launch.

The international company is a privately owned organisation which has grown organically over the past five decades now employing over 5,000 highly skilled personnel across 17 facilities including Europe, the US and Asia.

The company has a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.