Production Featured Articles

  1. Essential Insights Into Pharmaceutical Product Release, Part 1 Of 2 12/27/2024

    Pharma product release ensures drug quality, safety, and regulatory compliance by evaluating manufacturing and quality processes. It’s a critical, comprehensive process essential for FDA approval and patient safety.

  2. AI's Promising Role In Adverse Event Management Of Small Molecule Drugs 12/27/2024

    By fostering a proactive, technology-driven environment, pharma manufacturers can ensure swift, accurate tracking of adverse events while advancing patient safety and meeting compliance standards.

  3. Can Our Current Operational Processes Survive In 2025 And Beyond? 12/19/2024

    As long as operating procedure improvements are confined to a single function or sub-area, the benefits will be limited to that context. What can we do for true process improvement across our organization?

  4. Optimizing Bioprocesses Using Functional DOE 12/18/2024

    Combining Functional Design of Experiments (Functional DOE) with traditional DOE methods enhances biopharmaceutical process optimization by capturing dynamic, time-based variations in cell culture systems.

  5. Survey Findings: How Are IDMP Readiness Efforts Progressing? 12/13/2024

    ISO Identification of Medicinal Products (IDMP) standards were designed to harmonize the way the life sciences industry records and manages data about its products. Companies’ state of readiness to implement and harness IDMP still varies.

  6. ICP-MS And ICP-OES: Tools For Elemental Impurity Analysis 12/11/2024

    Leverage advanced elemental impurity testing methods to ensure the safety, compliance, and accuracy of your drug products throughout the manufacturing process.

  7. The 5 Key Risks Of Failing To Select The Right CDMO Partner 12/11/2024

    For complex projects involving oral solid dosage (OSD) and sterile drug products, selecting the ideal CDMO can play a pivotal role in determining the success of a drug candidate.

  8. Viewing HEK293 Transient Transfection Through A Wider Lens 12/11/2024

    HEK293 transient transfection is a leading platform for gene therapies. However, manufacturing challenges remain, particularly in scaling up production.

  9. Stage 3a: A Key Indicator For Process Validation Maturity 12/9/2024

    Process validation's stage 3a serves to reconfirm the assumptions made during design space development and is particularly pronounced for new modalities and emerging processes.

  10. Best Practices For Chromatography Column Packing 12/6/2024

    Proper packing for resin is crucial to prevent issues like cracking or channeling which can lead to process disruptions and product loss.