Guest Columns
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Understanding The FDA’s Current Focus On Risk Evaluation And Mitigation Strategies
9/21/2023
The FDA recently asked for comments about how the government handles vendor change requests from drug sponsors with risk evaluation and mitigation strategies. So, we asked a REMS expert to help us understand why the agency is focusing on the broad-reaching program and what it could mean for drug manufacturers with REMS products in their portfolios.
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Essential Elements Of Technology Transfer
9/19/2023
The principles of an effective technology transfer can apply at every stage of the drug development lifecycle for biotech companies of every size. Tech transfer programs are usually bespoke, but they share common essential elements. This article breaks them down.
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Risk Tool Selection With ICH Q9(R1) In Mind
9/19/2023
This article focuses on the formality concept discussed in the revision of ICH Q9 Quality Risk Management released earlier in 2023. The authors provide a helpful overview of what risk tools are appropriate to use during certain types of scenarios, and what the team composition should look like.
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Moving From Clinical Stage To Commercial? 4 Steps For An Outsourcing Strategy
9/18/2023
If you're a pre-commercial bio/pharma looking ahead to commercial stage, evaluating partnerships are faced with making key decisions around which capabilities to outsource, the degree of data access and ownership, and which external partners are the right fit. Here are four key actions to consider.
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Emerging Market Trends For APIs
9/15/2023
The active pharmaceutical ingredient (API) market is estimated at $158 billion in 2023 and is projected to reach $232 billion by 2028. This article shares new market research on APIs, including an analysis of innovative and generic APIs, synthetic and biotech APIs, and more.
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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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New ISO 14644-21:2023 Addresses Reducing Sampling Errors With Airborne Particle Counters
9/11/2023
The new ISO 14644 Part 21 addresses optimizing particle counter accuracy in cleanrooms, focusing on reducing sampling error and particle loss. Discussion includes the use of airborne particle counters, tubing, and isokinetic probes.
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Survey Results Show What Could Finally Make Sustainability Stick
9/8/2023
Results from BioPlan's "20th Annual Report of Biopharmaceutical Manufacturing and Production" show that lasting sustainability strategies should focus on profitability aspects. That's because, even more than a spirit of stewardship, financial advantages provide a powerful incentive to stick to the plan.
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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.