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Pharmaceutical Manufacturing and Packing Sourcer

From Delivery to Dispensation



Drug development is evolving. Clinical trials are not only becoming larger in scale but more complex in nature. Biologics are superseding small molecule, high stability profile therapeutics – placing an onus on sponsors and CROs to develop effective strategies of maintaining strict temperature conditions and precise handling controls throughout a drug’s lifecycle.

The emergence of advanced cell and gene therapies is creating new demand for next-generation, ultra-low, cryogenic supply chain strategies. With the advanced therapy market becoming more competitive, and expected to grow significantly in the coming years, attention is being paid to the solutions and technologies available to store, process, and distribute the highly sensitive products. From vapour shippers and use of building management systems (to monitor vessels and environmental conditions) to strategies to improve efficiency of receiving, labelling, and distributing materials, while ensuring minimal time out of ultra-low temperature conditions. With such high-value investigational medicinal products (IMPs) leaving little margin for error, and with patient safety firmly in mind, recognition of the importance of creating end-toend temperature data visibility is also increasing.

Regulation is a key driver for sponsors and CROs to prioritise end-to-end data visibility. GDP places a regulatory requirement on sponsors to collect all temperature data to prove an IMP has maintained ideal storage conditions through each phase of the clinical supply chain. The guidelines also require that data are readily accessible, and that sponsors utilise a process for effectively investigating excursions.

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Sarah Smyth graduated from Queen’s University Belfast, Northern Ireland, with a BEd in Business Studies. After graduating, Sarah gained a wide range of experience working in the clinical diagnostics industry, especially around solutions regarding shipping temperature-sensitive products in challenging climates. In 2016, she joined Almac and has since worked with a large number of pharma and biotech companies initially in developing proposals to fulfil packaging and distribution needs, aiding in the successful delivery of a range of clinical trials. More recently, Sarah has worked closely with clients to understand the challenges they face with distributing temperature-sensitive drug products and advising on the best solutions to implement for efficient management of temperature data on a global scale

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