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Sharp’s expertise in package design, production engineering and serialization helped MT Pharma achieve their first US launch deadline for Radicava™.

Radicava™ from MT Pharma America is the first FDA-approved treatment option for ALS in more than 22 years. It is an intravenous infusion treatment option for amyotrophic lateral sclerosis (ALS), a rapidly progressive neurodegenerative disease that causes people to lose their ability to perform the basic functions of daily living.

“This project would not have been possible without Sharp’s exceptional support, team effort and shared history.  Today we made history in providing this treatment option for people with ALS.  We look forward to changing lives, evolving partnerships and making history together.” Christopher Galliardo, MT Pharma America. 

The Challenge Identified

MT Pharma approached Sharp in Allentown for a packaging solution ahead of their US launch for Radicava, their very first product to launch as a US company. The Radicava packaging had been previously designed and distributed in Japan, in the form of 10 IV bags in one large carton. MT Pharma also needed a serialized solution in time for this US launch.

The Sharp Solution

Using the flexible ‘PACS’ (Print Aggregation Conveyor System) line the Sharp engineering team proposed several different carton design options that would better accommodate the dosing requirements needed for the US market while also saving on the cost of each lot packaged. By reducing the carton size to hold only two IV bags instead of ten, the package would be easier to distribute and store for hospitals and pharmacies. The artwork for the Radicava packaging – which also included brand-marked tamper-evidence seals – was adjusted by our design team to accommodate the necessary serialization data. The Radicava packaging has three layers of serialization; from carton, to shipper, to pallet which was fully implemented within a 3-month timeframe.

As with most serialized packaging projects in Sharp, the project team was drawn from a cross-functional group of packaging experts in quality, project management, validation, operations, customer service and engineering. The validation and project management teams worked with MT Pharma to ensure there were two validated packaging rooms ready-to-go, in order to facilitate the quantities demanded for the launch. Together they worked to deliver Radicava into distribution in time for MT Pharma’s end of July US product launch.

The Positive Outcome

Naturally, with a product of this nature, the turnaround time to distribution was critical. Within three days of Radicava™ receiving FDA approval in June, Sharp had completed five packaged lots ready for distribution and all 40 lots – or 144,000 serialised cartons – were packaged and distributed without any supply restrictions to patients.

The Patient Impact

We live our values every day at Sharp. Whether through the ingenuity of our design and production engineers, the partnership of our business development and customer service teams, the expertise of project management group or the energy of our validation team – each of them brought an energy and commitment to this project that delighted our customer and ultimately made a difference to patients’ lives.

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