As time goes on and researchers search for new treatments, one thing has become abundantly clear—a one-size-fits-all approach to treating patients doesn’t always work. Such a revelation leads to innovations, like personalized medicines. In the article, “What’s Driving Personalized Medicine,” a representative from Genentech reveals some of the advantages and trends of this new treatment.
However, new treatments—like personalized medicine and cellular therapies—present their own unique challenges, such as supply chain complexities. While new clinical trials recruit and utilize regenerative medicine, many of these therapies are created using a patient’s own cells, which means that acquiring the patient’s cells, manufacturing the drug, and shipping it back to the clinical trial facility can be a bit tricky—without the need to factor in these drugs’ zero tolerance for any temperature deviations. (Check out “Supply Chain Challenges with New Therapies” to learn more.)
This is further complicated by new legislations and laws, such as the Drug Supply Chain Security Act (DSCSA), that will impact the ultimate pharmaceutical supply chain. With the nearest deadline of manufacturers having to serialize their products in November of 2017, many companies are hurrying to change and/or implement new processes. To learn more about the DSCSA and the steps leading to the November 2023 unit-level traceability deadline, find your way over to the article “DSCSA Implementation: Steps & Challenges.”
I could go on about acquiring on-demand talent for these new initiatives in the pharmaceutical industry or process instrumentation calibration challenges, but I’ll let you check out the articles in this issue of Pharmaceutical Processing for more information about those.
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