Insights On Quality Control

  1. Lentiviral Vector Upstream Process 12/12/2025

    Scalable lentiviral vector production is moving beyond adherent systems. Learn how streamlined workflows enable linear scale-up in stirred-tank bioreactors for cost-effective gene therapy manufacturing.

  2. Mobile Gowning Cleanroom, Built To Meet ISO 7 Requirements 6/19/2024

    Uncover how Germfree designed and installed a mobile cGMP cleanroom on a 53′ tractor-trailer chassis to provide a flexible and efficient cleanroom solution tailored to the company’s needs.

  3. HPLC Autosampler Performance I: Challenging USP Methods 9/16/2024

    In this study, the injection precision of an Alliance iS HPLC System was evaluated using four compendial HPLC methods from the USP with challenging method conditions and strict system suitability criteria.

  4. Quantitative Determination Of Amorphous And Crystalline Drug In Polymer Microspheres 12/30/2024

    Biodegradable polymer microspheres control drug release through crystalline and amorphous properties, analyzed using DSC, MDSC, and TGA to determine composition and stability for precise delivery.

  5. Achieve Complete Confidence In Your QC Lab Data 3/21/2024

    In today's fast-paced global economy, maintaining data quality in chromatography analysis is more difficult than ever before. Discover how you can achieve complete confidence in your QC lab data.

  6. Lessons From FDA 483s And Warning Letters: Cleanroom Compliance 12/8/2025

    Learn critical lessons from FDA 483 observations and Warning Letters to proactively address common GMP cleanroom compliance failures and build an inspection-ready facility.

  7. Optimizing Contamination Control: Strategy Planning And Execution 7/25/2025

    A robust contamination control strategy using a plan-do-study-act framework ensures compliance, product quality, and operational efficiency in biopharmaceutical manufacturing facilities.

  8. Experience The Future Of Bioseparations 4/16/2024

    Learn about an HPLC System designed to improve outcomes in QC labs with ease of use and simplicity at its core.

  9. Digitalizing Pharma Control Strategies: A Roadmap 1/24/2025

    Digitalizing control strategies in pharmaceutical manufacturing enhances product quality, compliance, and efficiency, leveraging data-driven approaches like QbD, and digital CPV for optimized processes.

  10. Water Activity And Primary Packaging For Oral Solid Dose Products 7/10/2024

    The draft of the general chapter USP<922> says water activity determination can be used to assess the level of protection of primary packaging for an oral solid dosage product over its entire shelf life.