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).
Contact information
Kjell Johansson, President Manufacturing Services Europe, kjell.johansson@recipharm.com, + 46 739 622 620
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About serialisation
Serialisation is a means to trace and track pharmaceuticals from manufacture through to prescription, using bar codes to record information about product origin, shelf life and batch. This will help the fight against counterfeit products entering the supply chain and ultimately improve patient safety.
About MARCHESINI GROUP
Born from an idea of Massimo Marchesini in 1974 in Pianoro (BO), where the headquarters are still based, Marchesini Group is a leader in the supply of complete lines and machines for pharmaceutical and cosmetic packaging. The numbers prove its success: a consolidated turnover of the entire Group amounted to 270 million Euro in 2015, with 1,200 employees, 14 manufacturing divisions, 7 acquired companies, a network of 35 agencies and 18 branch offices. Thanks to the constant commitment for innovation, today Marchesini is a protagonist in the Italian and international markets: 87% of its turnover is generated by exports. Despite a strong international focus, Marchesini Group’s strength and distinguishing feature is that it bases its production entirely in Italy, guaranteeing high-quality products while enhancing its relationship with the localized economy.
For more information, please visit: http://www.marchesini.com/
About SEA Vision
For over 20 years, SEA Vision has been a leading vision systems provider for the pharmaceutical sector and owes its success to the quality of its technological solutions. Today SEA Vision has successfully supplied over 250 full track and trace systems and more than 3500 vision systems worldwide. Through consolidated expertise and continuous commitment to research and development, SEA Vision offers tailored solutions for cutting-edge projects with high complexity. Thanks to a network of sales & service facilities located in all major global markets, SEA Vision provides its worldwide customers with technical on-site support assistance.
For more information, visit: http://www.seavision.it/
About TraceLink
TraceLink is the world’s largest track and trace network for connecting the life sciences supply chain and eliminating counterfeit prescription drugs from the global marketplace. Leading businesses, including 16 of the top-20 global pharmaceutical companies, trust the TraceLink Life Sciences Cloud to deliver complete global connectivity, visibility and traceability of pharmaceuticals from ingredient to patient. A single point and click connection to the Life Sciences Cloud creates a supply chain control tower that delivers the information, insight and collaboration needed to improve performance and reduce risk across global supply, manufacturing and distribution operations.
Including Deloitte’s Technology Fast 500 (ranked number 293 in 2015), the Amazon AWS Global Start-Up Challenge Grand Prize, and the Edison Award for Innovation in Health Management, the Life Sciences Cloud is used by businesses across the globe to meet strategic goals in ensuring global compliance, fighting drug counterfeiting, improving on-time and in-full delivery, protecting product quality and reducing operational cost.
For more information, please visit http://www.tracelink.com/.
TraceLink is funded by FirstMark Capital, Volition Capital and F-Prime Capital.
