Liquid Dose Featured Articles
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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.
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Your Best Chance At Regulatory Compliance For Combination Products: Integrated Development
9/14/2023
The FDA now defines a prefilled syringe, a product that was at one point considered “packaging” for a drug, as a constituent part of a combination product. The ultimate combination of the drug, its package, and its delivery device means that during development and manufacturing you need to combine both drug and device current good manufacturing practices (cGMPs) and quality approaches.
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Have You Adopted A Manufacturing Execution System Yet?
9/7/2023
Manufacturing execution systems (MES) have become crucial in managing bio/pharmaceutical operations to ensure compliance and promote efficiency. This article shares the benefits of adopting a MES, the three deployment options, manufacturing applications for MES, and more.
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Ready-To-Use Containers: A Smart Approach To Fill & Finish Operations
8/25/2023
RTU containers are in demand, as they are supplied pre-washed and pre-sterilized and can be integrated directly into aseptic Fill & Finish lines. Find out about the latest RTU containment solutions.
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FDA Issues Second DSCSA Warning Letter — What Does This Mean?
8/16/2023
In June 2023, shortly before final requirements of the Drug Supply Chain Security Act (DSCSA) must be met come November, the FDA issued a warning letter to Safe Chain Solutions, LLC addressing DSCSA violations related to repeated instances of distributing costly counterfeit antiviral drugs that Safe Chain had sourced from unauthorized trading partners. Let's look more closely at the emerging themes so that you can avoid a similar warning letter.
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Market Watch And Perspectives On Vaccines Manufacturing In APAC
8/16/2023
Nearly forty biopharmaceutical companies, CDMOs, and research institute executives took part in interviews on the future of vaccine manufacturing. Explore the key findings following these interviews.
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Financial Leadership Of Strategic Procurement: 4 Foundational Steps
8/2/2023
Efficiently managing a diverse supply base is crucial for drug companies to maintain growth, profitability, and compliance. While the procurement function can be organized under various executives, the relationship between the CFO, procurement, legal, and buying departments is very important.
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An Independent Expert’s Guide To Picking Nanoparticle Manufacturing Equipment
7/26/2023
Until recently, nanoparticle manufacturers had to change equipment between preclinical, clinical, and commercial phases. Advances in technology offer more flexibility allowing manufacturers to turn up the dial on the same machines — from early development all the way to commercialization.
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Preparing A Framework For Artificial Intelligence And Machine Learning Validation: A 3-Step Approach
7/20/2023
Experts say it would be foolish to ignore the impending AI/ML revolution. There's official guidance out there now on how to prepare, but waiting for a full framework from regulators would be a mistake. This article lays out some strategies for building a foundation to implement AI/ML into your processes.