FEATURED ARTICLES

How does the cell and gene therapy supply chain team stay ahead of the expected changes and respond at the speed the developing program expects? Supplier selection, raw materials, built-in quality, warehousing and logistics, and traceability are all covered in this article.
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Cell & Gene Therapies Require the Right Tracking Solution
In cell therapy trials, the ability to track a patient’s cells is essential. When you have over 100 patients, and the cells will require multiple shipments, using a spreadsheet is not possible. “For the safety of our patient, accurate tracking is a must,” says Gerald Garrett, VP of clinical operations for MarkerTherapeutics. “We need to know exactly where the product is at any step of the way.”
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Supply Chain Success Relies On Collaborative Decisions
If you work in clinical operations, you’re probably aware of how closely that function must work with manufacturing. There are numerous decisions that have to be made around clinical packaging, interactive response technology (IRT) software, labeling of the clinical supplies, and the actual logistics of getting the supplies to the right place at the right time.
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10 Things To Remember About The QP Role And Process
The QP process is a necessary process that every sponsor company wishing to undertake trials in, or move product through the European Union must undergo. When faced with this process, many companies are unsure as to what to expect.