Case Study

The Benefits Of Late-Stage Customization For Orphan Drug Manufacturing

The Benefits Of Late-Stage Customization For Orphan Drug Manufacturing

Almac explains how, through the use of the Hapa BlisterJet printer, they are able to maximize the stock flexibility of their clients’ valuable orphan drug products, meaning they can distribute product more efficiently between different European countries.

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 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. “Our clients benefit from processing their drug products just in time and tailoring their stock to the market by having increased flexibility, reduced stock holding, minimised costs and reduced lead-time to the end-user, the patient.”

Why does customisation need to happen at the last minute?
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.

A thriving partnership
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 facilty, 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 card 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.

About Almac Pharma Services
Almac is an established CDMO, with a global reputation for excellence built with over 50 years of client service. We deliver expertise throughout the drug development to commercialisation lifecycle. Working with our client partners, we provide tailored solutions to meet their unique pharmaceutical development, manufacturing and packaging outsourcing needs by forming strategic relationships based on collaboration, integrity and responsiveness.

With facilities in the UK, EU & US, our global presence and local expertise provides flexible, quality led solutions to serve the following areas; drug product development, analytical support, high potency processing, clinical and commercial drug product manufacturing, commercial packaging of solid oral dose, sterile presentations and medical kits, serialisation, product launch and EU 3PL services.

About Hapa
Hapa’s mission is to empower their customers to improve lean production with printing solutions that add value to packaging processes. Hapa are a proud supplier to nearly all of the major pharmaceutical companies worldwide.

Hapa is a proud member of Coesia, a group of innovation-based industrial solutions companies operating globally and headquartered in Bologna, Italy.