Featured Pharma Online Editorial

  1. Bacterial Endotoxin Testing, Part 1: Overview 7/16/2024

    All injectable drug products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins. This article provides an overview of bacterial endotoxin testing and the LAL method.

  2. 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.

  3. Balanced Sourcing Of Custom Media/Buffer Formulations, Part 2: The Case For Insourcing 6/6/2024

    In part 1 of this 2-part series, the authors discussed the case for outsourcing of custom media/buffer formulations. In this article, they discuss key considerations in the case for vertical integration, or insourcing.

  4. Is Excessive Pressure in The Feed Frame Causing You Problems? 6/5/2024

    Are you having content uniformity issues in oral solid dosage manufacturing? Your slide gates and valves might not be in the best position with relationship to the powder feeder.

  5. AI Integration In Drug Manufacturing: GMP Insights For Operational Excellence, Regulatory Compliance 6/4/2024

    This article provides insights into a variety of use cases on the application of AI/ML in GMP settings and 5 key considerations for drug manufacturers using AI.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Quality Imperatives In Oral Solid Dosage Manufacturing: An Overview 5/2/2024

    This article overviews the critical aspects of OSD manufacturing and the importance of understanding and implementing regulatory guidelines within the context of quality.