Featured Pharma Online Editorial
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Driving Pharma/Biotech Capacity With Smart Manufacturing
1/24/2024
It is time for pharma/biotech manufacturers to consider a new approach to capacity management, one that can not only resolve today’s challenges but also position the enterprise to drive innovation and resilience in the future. You can leverage a smart manufacturing approach in three vital ways.
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Are Single-Use Technologies Always The Answer?
1/9/2024
It is clear that single-use technologies (SUTs) have won the war over reusable stainless steel. However, beneath the surface, there is a web of considerations that challenge the belief that SUTs are unequivocally cost-effective. Let's look at cost considerations as well as risk considerations.
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WHO’s 6 Principles For An AI Regulatory Framework For Medical Product Development
12/14/2023
In mid-Oct. 2023, the WHO published a paper titled Regulatory Considerations on Artificial Intelligence for Health, identifying the key principles that international regulatory frameworks for artificial intelligence (AI) should address and are, in fact, starting to coalesce around. The paper was developed in consultation with a WHO Working Group whose members include regulatory authorities, policy makers, and more.
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How Does The GAMP 5 Second Edition Update Look One Year Later?
12/12/2023
Since ISPE published the GAMP 5 update last year, companies say the flexible approach to computerized system validation is helpful, but the new focus on critical thinking remains a challenge.
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Pacesetters Are Product Innovators Who Embrace Digital Process Enhancement
12/12/2023
The Josh Bersin Company recently underwent research examining pharma/biotech “pacesetters” in the field. We caught up with Jordan Schmitting, senior research analyst at The Josh Bersin Company, to discuss the trends illuminated by the research.
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How Can Digital Twins Get Us Closer To Pharma 4.0?
11/28/2023
Digital twins — virtual representations of physical and conceptual assets, processes, or systems — offer a seamless bridge between the present challenges and the vision of Pharma 4.0.
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Enteric Gel Capsules Market Flourishes As Demand For Advanced Drug Delivery Surges
11/7/2023
Enteric gel capsules ensure medications are released in the small intestine rather than the stomach, enhancing drug efficacy while minimizing gastrointestinal side effects, and making them a preferred choice for patients. This article examines new market research insights.
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FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities
10/25/2023
The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.
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5 Key Considerations For MES Vendor Selection
10/20/2023
Have you made a strategic business decision to implement a manufacturing execution system (MES)? Selecting a MES vendor is a strategic and thoughtful process. With these five considerations, you can give some thought to how MES fits into your enterprise landscape and your business requirements.
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How To Lose A Batch In 10 Days
9/25/2023
Inspired by the rom com How to Lose a Guy in 10 Days, this article spotlights the critical missteps that could lead you to lose a batch during the manufacturing process. By identifying these pitfalls, the author guides you toward best practices that will not only save your batches but also improve the quality, efficiency, and reliability of your operations.