PBD BIOTECH – Diagnostic Kit assembly, logistics & distribution.

Vial | Sample | Integrity | Cryoniss

As temperature controlled storage and logistics management experts, Cryoniss are perfectly placed to project
manage your diagnostic kit assembly and distribution requirements.

Working to GxP and licensed by the MHRA for Good Distribution Practice, our knowledge and experience of the regulatory minefield surrounding manufactured products
means that handing your bespoke diagnostic kit assembly over to us will save you sleepless nights, and valuable time.

PBD Biotech are developers of phage-based diagnostics including a rapid blood test that can be used to screen at risk populations and identify those at risk of developing
tuberculosis. A quarter of the world’s population is estimated to carry tuberculosis infection, of which 5–10% will develop disease over the course of their lives. The challenge
facing human health professionals is how to target preventive therapy effectively and this is a pillar of the WHO’s #EndTB campaign.

Prior to this project, PBD already had a manufacturer engaged in the building of their kits, and Cryoniss’ role was focused solely on the secure storage of both the kits and
their components, and coordinating the logistic requirements. As this relationship developed and in line with bespoke quality checks that we had already agreed with PBD,
Cryoniss noticed specific improvements that could be made to the design and packaging of the kits. Both companies realised that as we were already storing the
components, and worked to the highest principles of GMP, a more streamlined, cost-effective and agile process could be developed by Cryoniss assembling the kits in-house.

Vial | Sample | Integrity | Cryoniss

Our first challenge was to design a robust, professional storage box that not only coped well with the refrigerated temperature required to store the kits but also held the various components securely and displayed them in sensible order for the user. It was vital to both Cryoniss and PBD that sustainability was prioritised, as well as a professional and hard-wearing product. We were delighted to engage Prior Packaging who supported us with design and sustainability suggestions, alongside providing exceptional response times and flexibility. Further to this, Cryoniss supported the printing of PBD designed labelling but utilising a local company, Merseyside Printing, also based at The Heath Business and Technical Park, limiting the carbon footprint and offering an agile, cooperative solution. The printers were able to offer and print DuraLabels which use a stronger bonding agent suitable for refrigerated storage and again enhancing the durability of the kits.

After designing bespoke procedures and assembly instructions which were reviewed by PBD’s quality department, Cryoniss operators had a clear blueprint of how the kits must be assembled. Numerous quality checks were embedded in the preparation, picking and assembly completion stages of the process which were fully audited by PBD’s quality department in the spirit of our open, transparent values. These bespoke procedures also allowed Cryoniss to streamline the process from the beginning, providing a large output of kits without the need for any additional resource.

Assembling the kits in house means they can safely put them immediately into storage and after the final quality sign off, be ready for retrieval and dispatch in a very short time frame. As per Cryoniss’ standard ways of working, all storage units used to hold the kits are temperature mapped and cleaned annually, as well as serviced twice yearly – this provides PBD with the confidence that their product is being stored and their brand protected in the best way possible.

With extensive knowledge of logistics requirements, it only seemed fitting that Cryoniss would provide logistical services for the transport of the diagnostics kits, from quick turnaround, simple service for domestic UK shipments to the more complex international requirements of overseas shipments.

Mondana Cook, Chief Operating Officer at PBD: “The team did a great job supporting us in the design of packaging and assembly particularly given the unknowns right up to the point of assembly day. Our audit report shows it all.”

Phil Hargreaves, our Facility Asset Manager, really enjoyed getting his teeth stuck into the project:

“Working directly with PBD, allowed us to really understand the requirements and variables as planning for the project progressed. We were able to make quick changes to accommodate the variables as they were finalised. This fed directly into our procedures, creating a streamlined and efficient services from the initial storage of kit material, through to the dispatch of the final produced product”

Kit Assembly Case Study | Cryoniss

“When we looked for a supplier to provide safe storage and shipment of our diagnostic components and samples; Cryoniss were the natural choice.

Their attention to detail is phenomenal and we know our products are in safe hands. Storing and distributing our products through Cryoniss means one less headache in our heavily regulated industry – worth its weight in gold.”

Jane Theaker CEO – PBD BIOTECH