Pharma Logistics Editorial
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A New Year For Novo Nordisk’s Wegovy Supply Challenges
12/8/2022
Those who follow this kind of news – and some who normally don’t – jumped on Novo Nordisk and Catalent for what is in fact a significant supply-chain challenge that came to light at the turn of the New Year. Now, a year later, we, too, take this up, but from a different perspective than previously presented.
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1 Year Out, Where Do We Stand On DSCSA Implementation?
11/21/2022
This month kicks off the final year of a decade-long process to enhance overall security of the U.S. prescription drug supply chain under the Drug Supply Chain Security Act. This article looks at this year’s DSCSA implementation efforts, before examining where implementation currently stands and what gaps and challenges remain.
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Digital Twins & The CGT Value Chain: A Universe Of Possibilities
10/21/2022
The cell and gene therapy revolution is coinciding with advanced digital technologies. At the forefront are digital twins, which combine at-scale computing, modeling methods, and IoT connectivity to create full-scale digital replicas of physical assets or real-world processes, such as factories, value chains, and even humans.
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Autonomous Supply Chain Planning Is Within Reach
10/19/2022
In a fast-paced industry constantly innovating — from personalized medicine to health wearables — life sciences companies must be prepared to adopt transformative technologies that can help them meet the demands of the future of medicine. Autonomous supply chain planning is not science fiction; it's here, and it's now. Building a practical road map will help.
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Lessons For Outsourcing: Can You Pass The Test?
10/3/2022
Back to class. Here's part 2 of our "Outsourcing Master Class," created by Darren Dasburg. We'll cover the final five of the 10 modules: provider selection; financial analysis; contracts; transitions; and governance. If you want to outsource better, sit up straight, and focus.
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The “Outsourcing Master Class”: 10 Modules For Success
9/26/2022
Darren Dasburg didn’t write the book on outsourcing. He did, though, design and teach the defining class on the subject. He then went on to executive roles at GSK, MedImmune(AZ), and CRISPR Biotech, where he put his teachings to work. Now he's back to teaching that class - right here for Outsourced Pharma readers.
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FDA, CDMOs, And COVID: How To Talk About 483s
9/23/2022
Let’s discuss our manufacturing partnerships, the innovation and investments required, and the spectacular quality it takes to produce a vaccine. When the FDA does its job and feels it must issue 483s, let’s put that into context, and educate the public on the rigors of drug development and manufacturing.
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The Process Map To Ensure Biopharma Raw Materials Supply
8/16/2022
In new product introduction, there is often a lack of a basic data package for a product being scaled up for clinical or launch supplies. This can lead to several issues, e.g., capacity and lead time restrictions, oversupply, and more. A stepwise process can be used as a guideline for introducing a material to support new drug substance manufacture.
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Key Considerations For Decarbonizing Your Biotech Facility
5/4/2022
Biopharmaceutical manufacturing processes do not directly utilize fossil fuels, but fossil fuels are used in the generation of raw materials, consumables, packaging, and in supplying energy to building systems and manufacturing equipment. This article looks at key facility decarbonizing considerations using a case study with quantification of estimated costs.
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Aiming To Solve The 3 Key Challenges Of CAR T-Cell Manufacturing
1/18/2022
These authors share their best practices for solving the three key challenges of CAR T-cell manufacturing (supply constraints, scalability issues, and storage and logistics challenges) using their experiences with Epstein Barr Virus (EBV) T cells.