Recipharm, the contract development and manufacturing organisation (CDMO), has formed a global partnership with Marchesini, SEA Vision and TraceLink to introduce new serialisation capabilities.
The announcement marks the next step in the global CDMO’s plans to invest €40m over the next three years to ensure state-of-the-art solutions for serialisation processes.
The investment will ensure that pharmaceutical companies accessing Recipharm’s manufacturing services will comply with the EU Falsified Medicines Directive (EUFMD) Safety Features Delegated Regulation, which makes serialisation of licensed drug products in Europe a legal requirement from early 2019.
After assessing various vendors, Recipharm selected Italian-based Marchesini and SEA Vision to meet its hardware and software requirements for serialisation at levels 1 (device level), 2 (line level) and 3 (site level). The company has also selected the TraceLink Life Sciences Cloud, the world’s largest pharmaceutical track and trace network, which will act as a level 4 central repository to meet the CDMO’s enterprise serialisation management and global tracking needs.
The complete serialisation solution will be implemented in 15 of Recipharm’s European locations and on more than 70 production lines. The company anticipates that a pilot showcase line will be operational from July 2016 to allow customers to view and trial Recipharm’s standard solution for serialisation and aggregation.
The CDMO’s company-wide serialisation project is being led by Staffan Widengren, Director Corporate Projects at Recipharm. He said: “At an early stage, we took the decision to lead the market and make a significant investment into state-of-the-art solutions to actively help pharmaceutical companies meet new drug serialisation requirements."
“Recipharm already provides serialised products in markets including Turkey, Korea and China so we understand that the process can be complex and time consuming, particularly if the right tools and expertise are not in place."
“We have undertaken an extensive evaluation process to ensure we partner with experts that will allow us to best support our customers on their serialisation journeys. It was clear that Marchesini and SEA Vision have a very strong relationship, which would allow us to seamlessly implement the hardware and software required for serialisation. As a global CDMO, the flexibility of a cloud-based central repository and the easy network connectivity to our pharma clients were also key factors in our decision to collaborate with TraceLink.”
The collaboration will see over 75 production lines equipped with Marchesini and SEA Vision machines and software during 2016-2018 to meet the various local requirements of each of the CDMO’s sites.
Marco Baietti, commercial director at SEA Vision, said: “As a CDMO, Recipharm is leading the way in preparing for serialisation and ensuring the challenge is high on its agenda. We are delighted to support the company on its serialisation journey and look forward to a successful partnership.”
Pietro Tomasi, commercial director at Marchesini Group added: “We are really pleased that a notable company such as Recipharm has chosen Marchesini Group to carry out this project. Our serialisation and track and trace solutions offer a high level of customisation and we look forward to working with Recipharm to ensure the company is well prepared for the new regulations.”
Recipharm serves 250+ customers and expects 85% of its production to require serialisation. The CDMO will also be ready for US serialisation from November 2017 in-line with the US Drug Supply Chain Security Act (DSCSA).