Pharma Logistics Editorial
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Development And Commercial: 2 Supply Chains For An Ideal Future
1/5/2024
How do you transition a supply chain utilized for your development stages to a robust commercial supply chain? Thierry Bilbault knows how. He does done it before, and is at it again. He shares his strategies and secrets.
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Cryo-Shippers: Challenges, Controls, And Logistics
1/3/2024
Cryo-shippers are essential for shipping advanced therapeutics, but how do you choose and validate the right one? This article from BMS experts offers insights.
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Emerging Trends & Technologies In Anti-Counterfeit Pharmaceutical Packaging
11/21/2023
Counterfeit medicines are rising at an alarming rate, with data showing that nearly 6,500 pharmaceutical crime incidents were recorded in 2021, ranging from innovator drugs to generics, and from antimalarials to blood pressure medicine to vaccines. What packaging and labeling strategies are pharma/biotech companies using to tackle this?
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Outsourcing And Phase-Appropriate GMP For Clinical Manufacturing Needs
11/20/2023
Appropriate manufacturing and timely delivery of investigational products are essential for the successful execution of clinical trials. This article shares best practices working with CDMOs as well as phase-appropriate GMP of the clinical supply.
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Leveraging An Application Managed Services (AMS) Provider For Pharma/Biotech Serialization Systems
11/16/2023
With the expansion of serialization requirements, including the need for Drug Supply Chain Security Act compliance, many pharma/biotech companies are turning to serialization technology systems to help them manage those specifications. This article shares the key benefits of leveraging an application managed services (AMS) provider as well as key considerations for selecting a provider.
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Which States Are Best To Locate Your Biotech?
11/13/2023
How would you go about looking for a modest-sized facility in the U.S. to establish your own development and clinical-stage manufacturing platform? How might a CDMO go about it today? We started this path of inquiry in our previous editorial. Today, the actual tour.
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1 More Year For DSCSA Prep: Pros, Cons, & What To Do Next
10/30/2023
The FDA recently announced that they do not intend to take action to enforce drug distribution security requirements under section 82(g)(1) of the FD&C Act until Nov. 27, 2024. What are the pros and cons of this announcement, and what should we do now? This expert shares his perspective and recommendations.
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FDA Announces 1-Year “Stabilization” Period For DSCSA Compliance — Don’t Mistake It For An Enforcement Delay
10/4/2023
On August 30 in a new guidance document, the FDA announced the establishment of a one-year stabilization period with regard to the enhanced security and unit-level electronic traceability requirements of the Drug Supply Chain Security Act (DSCSA) that go into effect on Nov. 27, 2023. The FDA makes it clear that this is not an opportunity to delay implementation; rather, it is an opportunity to refine, improve, and stabilize your systems and processes.
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FDA Gives More Time To Comply With Certain DSCSA Requirements
9/27/2023
To the relief of pharmaceutical companies and their trading partners, the FDA has paused enforcement of some Drug Supply Chain Security Act requirements. The agency warns that it's not an excuse to delay compliance.
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What We Can Learn From The Cancer Drug Shortages
8/30/2023
The dramatic shortage of essential cancer drugs, including cisplatin and carboplatin, has exposed gaps in the pharmaceutical supply chain. Here's what we can learn from it about building resilience and how alternatives like monoclonal antibodies can help reduce reliance on cornerstone therapies.