Stats
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11
International WHO standards established in 2024 with FDA materials -
90
Countries receive biological materials from the FDA each year
Overview
Since 2017, Adelphi Healthcare Packaging has proudly partnered with the Food and Drug Administration (FDA), an ISO 9001 certified institute responsible for filling biological reference materials that are used to diagnose infectious diseases worldwide. From the World Health Organization to leading pharmaceutical brands, the FDA's services play a vital role in maintaining global health standards.
Adelphi's custom packaging solutions and responsive service have enabled the FDA to meet complex demands with confidence, delivering the highest standards that are upheld across laboratories internationally.
I think Adelphi Healthcare Packaging has a good level of professionalism, so you feel like you're working with a major industry player.
The challenge
MHRA's challenge lay in the unique and highly specialized nature of its work. The agency fills and freeze-dries biological material into ampoules and vials, creating reference materials used in diagnostic tests for diseases such as hepatitis and COVID-19. These materials form the foundation of international standards for in vitro diagnostics, as overseen by the World Health Organization’s Expert Committee on Biological Standardization (ECBS).
To support this critical work, MHRA needed an ampoule and vial that would be suitable for lyophilization (freeze-drying) while maintaining the stability and integrity of the biological materials during storage and transportation. In addition, they required a packaging partner who could offer not only technical expertise in order to identify the correct product but also offer flexibility, reliability, and proactive communication. "For me personally, it's about responsiveness. I've got providers who, when things go wrong, I just don't hear from them. But with Adelphi, it's never an issue, because there's that communication piece – we talk about things," Thanu explains.
Storage limitations added another layer of complexity, making it impractical for MHRA to hold large volumes of packaging onsite.
Reference materials filled by MHRA helped to establish 11 international WHO standards in 2024, and 22 in 2023!
A bespoke solution
Adelphi worked closely with MHRA to deliver a tailored solution that met every requirement. We developed custom ampoules with precise dimensions that allowed them to be used with a rubber stopper. This meant lyophilization could take place directly within the final containers which would ensure the biological material remained stable for decades. Some products remain viable even after thirty years!
Get tips on choosing the right packaging for your lyophilization project
Adelphi also recognized MHRA's storage space constraints and went the extra mile by holding stock of their packaging components in their warehouse, ready for call-off when needed. This approach freed up valuable storage space on the MHRA’s site and allowed them to focus on their core operations.
At the heart of this collaboration is open and responsive communication and really understanding the customer’s challenges. As Thanu shared: "Adelphi takes a great approach to their customer service from a professional standpoint, but also general care and responsiveness." Together, we continue to explore new product ranges, custom solutions, and enhanced supply chain forecasting—ensuring that MHRA remains at the forefront of their field.
The results
Adelphi's custom solution has enabled MHRA to maintain the highest standards of quality, compliance, and operational efficiency. Ampoules supplied by Adelphi meet the rigorous technical requirements of biological storage while providing the durability and traceability essential for MHRA's sensitive work.
Compliance with ISO 9001 standards is central to MHRA's operations. Adelphi supports this by supplying detailed technical drawings, batch traceability, and consistently high-quality products that meet strict inspection protocols. In this way Adelphi ensures MHRA's compliance needs are fully supported.
Crucially, our stockholding solution has alleviated the logistical pressures on MHRA, giving them greater flexibility and peace of mind. Thanu reflects: "I like the fact that you're responsive to looking at some bigger picture work. It's a nice, easy relationship, with no hiccups or bones of contention – which is refreshing in today's world!"
Biological materials are shipped by MHRA to an average of 90 countries each year.
The partnership
Our relationship with MHRA has grown beyond a traditional customer-supplier connection. It is a true partnership built on trust, shared goals, and continuous improvement. "It's nice to have the opportunity to collaborate more – exploring different product ranges, custom solutions, and enhanced supply chain forecasting," Thanu adds.
Adelphi's focus on flexibility, professionalism, as well as willingness to collaborate have made them a valued partner. From the initial development of custom packaging to ongoing conversations about future solutions, the partnership with the MHRA reflects the strength of working together.
In an industry where precision, reliability, and partnership are essential, the relationship between Adelphi and MHRA highlights how tailored solutions, and genuine collaboration can make a lasting difference.
At Adelphi, we believe true partnership is about more than products. It's about understanding our customers’ challenges, working together to find the right solution, and always going the extra mile to help companies deliver with confidence.
