Liquid Dose Featured Articles
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Beware AI Hallucinations
6/7/2024
As the use of AI increases and expands to new functional areas within biopharmaceutical companies, leaders must understand the risks and mitigate the impact of hallucinations in AI model outputs.
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Defining And Overcoming Batch Release Deviations
5/31/2024
Agencies lack a specific definition for deviations, so it’s up to each company to clearly define what they are, and then build systems to prevent and react to them.
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EMA Updates Guidance On Inhalation And Nasal Product Quality
5/29/2024
The EMA has issued a new draft guideline, “Guideline On The Pharmaceutical Quality Of Inhalation And Nasal Medicinal Products.” The public comment period ends Oct. 31.
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7 Steps To Accelerate Biopharma Manufacturing Processes
5/21/2024
Now more than ever, manufacturing capability can make or break success. To navigate the challenges, small biopharma companies must adopt these strategic approaches.
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A Holistic Approach To Container Closure Integrity
5/20/2024
Regulations are pushing for an approach to container closure integrity that builds quality into the design and processes rather than testing/inspecting the manufactured item.
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How To Unlock Efficiency In MES Integrations
5/16/2024
This article outlines the significant benefits and framework for manufacturing execution system (MES) integration with systems such as enterprise resource planning.
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Innovation For Subcutaneous Delivery Of Large-Volume Complex Biologics
5/9/2024
Explore the key findings of a new wearable injector clinical trial, including its positive impact on patient experience and the broader benefits of wearable injectors for chronic disease management.
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Delivering On GLP-1 Demand: Combining Device And Supply Strategy
5/7/2024
Meeting the demand for GLP-1 treatments requires robust and efficient delivery systems. Review how innovative solutions offer customization, streamlined manufacturing, and formulation compatibility.
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Nitrosamines: New WHO Guidance Provides Expanded Risk Assessment Considerations
5/6/2024
Nitrosamines are potential contaminants of drug products. Contamination can occur from synthesizing APIs and excipients, from leaching into the product from primary packaging, and more.
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Host Cell Impurities, Bioassays, Micro-Flow Imaging
4/9/2024
Ensuring the safety and efficacy of cutting-edge biopharmaceuticals hinges on meticulous quality control measures. Explore the role of qPCR and MFI in safeguarding drugs from potential contamination.