The International Society for Cell & Gene Therapy (ISCT) brought together over 3,000 global delegates from academia, regulatory bodies and the industry to discuss advancements in cell and gene therapy.

On Friday May 9th 2025, Damian Grantham, Product Manager for MAK-SYSTEM’s Cosmas, was part of a panel discussing the advantages of consistent informatics and data management systems in CGT manufacturing.

The session addressed the challenges and opportunities for building software systems that meet regulatory requirements that deliver safety, compliance and control for CGT manufacturers.

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MAK-SYSTEM is proud to be the partner of Northern Ireland Blood Transfusion Service to deliver safe, compliant and efficient blood management to patients, donors and clinicians.

The partnership was announced by NI Health Minister Robin Swann on May 15th 2024.

MAK-SYSTEM’s state of the art blood management system brings innovation and modernity to NIBTS. ,replacing a system that is over 25 years old. It will be the first of its kind in the UK and Europe, enabling blood to be fully tracked from donation to recipient.

When implemented, blood donors will be able to register to donate blood, book a donation session and complete a health check questionnaire via an online portal. Blood components will then be tracked on distribution to Trust Hospitals and onwards to clinical area for end use.

The system will also allow for full visibility of the blood stock inventory across NI at any time, facilitating greater sharing and more efficient use of blood and blood components across the region.

Karin Jackson, Chief Executive of the NI Blood Transfusion Service said: “Northern Ireland is leading the way in the development of a unique and very exciting blood transfusion transformation project. We are replacing a system which is over 25 years old and, for the first time ever, it will be possible to interrogate the entire blood transfusion system digitally, which will provide information and insight not previously available.

We are delighted to have contracted with MAK-SYSTEM Ltd which has a track record in delivering this technology to blood establishments worldwide. On completion of the regional implementation, a fully functioning digital ‘vein to vein’ donor management, blood production and tracking system will be in place, which will support safe, quality patient care. This will deliver benefits including enhanced processes for staff, improved donor experience, and a more efficient blood supply chain for Northern Ireland.”.

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MAK.care is the first Global Platform for blood and biologics, delivered as a service. 

New Zealand Blood Service now has full end to end automation of the nationwide vein-to vein operations from blood donation to transfusion, securely managed in the cloud by MAK-SYSTEM on the MAK.care platform

New Zealand Blood Service are the first national service managing blood and other controlled human substances to transition to MAK.care.

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On 3rd November FDA informed us that our blood establishment computer system ePROGESA v5.0.3, is cleared under the 510(k) regulatory pathway and can be promoted and sold in the U.S. This 510(k) clearance establishes the foundation to further enable the ePROGESA MAK.care initiative on the AWS cloud.

Since our last ePROGESA 510(k) clearance several functional and technical changes have occurred since then with one of the most recent being hosting ePROGESA on the cloud, in addition to the traditional on-prem option.

MAK is proud that with the support of our clients we can demonstrate that ePROGESA is safe and effective, both on-prem and on-cloud.

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COSMAS is now a CE-marked In Vitro Diagnostic medical device and can be sold in the European Union as of November 1st. Our COSMAS team and Quality & regulatory team planned the CE mark documentation submission throughout the summer and was prepared and delivered to our European Authorized Representative on October 27th.

On 1st November, the European Authorized Representative informed us that the verification had been completed and that COSMAS had been registered with their competent authority for medical devices. The CE mark is a huge achievement as it supports the first implementation of the COSMAS in the world.

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Damjan used the opportunity to present our platform MAK.Care, which truly marks the beginning of a completely new age of digital transformation in transfusion medicine and gene therapies.

MAK-SYSTEM is also honoured to be a platinum sponsor of the 6th Congress of the Macedonian Association for Transfusion Medicine, which is supported by the International Society for Blood Transfusion (ISBT). Stop by our booth to say hi to Sheila Campbell, Dushica Jovanova and Marija Spirovska to learn more.

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The Association for the Advancement of Blood and Biotherapies conference will be hosted in the heart of Nashville, Tennessee, and brings attendees from around the globe together to educate, network, and partner on the latest challenges and initiatives in the industry. With over 5,000 attendees, AABB hosts individuals from blood centers, hospitals, and cell therapy labs from around the world.

Stop by stand 1033 to learn more about MAK-SYSTEM and say hi to our team, with representation from across our business, including commercial, product, technology, and customer success who will be showcasing our innovative tech solutions for blood management.

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MAK-SYSTEM partners with New York Blood Centre Enterprises (yahoo.com)

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MAK-SYSTEM announces strategic partnership with AWS (htworld.co.uk)

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