Calibrating cold chain systems for cell and gene therapies in a post ...
Pharmaceutical supply chain partners are working to improve cold chain logistics for the transportation of cell and gene therapies. The COVID-19 pandemic has prompted the development of more efficient cold chain systems, with the approval of new cell therapies and the experience gained from transporting vaccines. The increasing demand for cell and gene therapies requires adequate storage and transportation systems to ensure their viability. The industry is investing in cold chain logistics, which accounted for nearly 18% of biopharma logistics spending in 2020. The continued advancement of cold chain logistics is crucial as the cell and gene therapy market is expected to exceed $81 billion by 2029.
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Frequently Asked Questions
Q: What is the focus of the article "Calibrating cold chain systems for cell and gene therapies in a post-pandemic world"?
A: The focus of the article is on creating an efficient cold chain system to transport cell and gene therapies in a post-pandemic world.
Q: Why is cryopreservation important in the delivery of cell and gene therapies?
A: Cryopreservation is important in the delivery of cell and gene therapies because it helps maintain post-thaw cell viability and performance.
Q: What challenges are introduced by cell and gene therapies in regards to supply chain?
A: Cell and gene therapies introduce unique supply chain challenges and considerations not seen in chemically synthesized therapies.
Q: What does FDA require regarding the description of CMC information for gene therapy products?
A: FDA requires sponsors of gene therapy products to describe the Chemistry, Manufacturing, and Control (CMC) information for investigational new drug products.
Q: What type of manufacturing practices are followed in cell and gene therapy?
A: Good Manufacturing Practices (GMP) are followed in cell and gene therapy manufacturing.
Q: What is the importance of proper storage and transportation systems in cell and gene therapy?
A: Proper storage and transportation systems are important in cell and gene therapy to ensure the viability and accuracy of the therapies.
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