Pharmaceutical Packaging Editorial
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AI Beats Back Bad Batches
9/21/2023
“I look from a supply-chain perspective,” says AI / supply-chain expert Tingling Dai, “discovery, development, manufacture ... until we put them into clinical use.” And that involves, he says, “keeping track of multiple stakeholders.”
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AI, The Ghost In The Outsourcing Machine
9/18/2023
It’s time to get real about artificial intelligence applied specifically to drug development and manufacturing outsourcing; practical supply-chain enhancements to implement right now. Thoughts from an AI supply-chain expert. Part 1.
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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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Global Market Trends For Drug–Device Combination Products
9/12/2023
Drug–device combination products, also known simply as combination products, have a wide range of applications, including drug-eluting stents, prefilled syringes with medications, inhalers with drugs, transdermal patches with therapeutic agents, and more. This article shares new market research.
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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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Takeda’s Green Approach To IG Purification And Filling
8/14/2023
To secure its spot as a 2023 ISPE Facility of the Year Awards winner, Takeda Lessines made some big moves including building a wastewater treatment center on-site in Belgium and installing 8,000 solar panels. This Q&A is part of a feature series on select FOYA winners.
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Container Closure Integrity Testing Strategies For Gene Therapies
6/7/2023
Container closure integrity testing (CCIT) has been recognized as having a significant impact on batch yield. This article provides perspectives on CCIT strategies to minimize the impact on gene therapy drug product batch yield by examining recent industry survey results as well as best practices.
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Let’s Explore Packaging For Aseptic Manufacturing
5/19/2023
When terminal sterilization is not an option, primary packaging materials have a fundamental role in preventing contamination. This article describes how packaging, including containers and closure systems, helps maintain sterility in aseptic manufacturing.
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5 Hot-Button Issues In Parenteral Packaging
5/16/2023
Five key issues related to parenteral drug packaging came to the forefront of the PDA Parenteral Packaging Conference held in Venice, Italy, in April.
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Risk-Based Strategies For Revalidating Bio/Pharma Equipment & Systems
4/20/2023
While equipment and systems validation is a regulatory requirement, it would take thousands of annual tests to retest all equipment and systems. BioPhorum shares risk-based approaches to new product introduction, controlled temperature chambers, sterilization processes, and more.