Insights On Quality Control

  1. The Seamless Path To Market: End-To-End CDMOs As Your Strategic Ally Douglas CDMO 5/14/2025

    Partner with an experienced end-to-end CDMO to streamline development, reduce risk, and accelerate your drug’s path to market in today’s complex and competitive pharmaceutical landscape.

  2. The Role Of Quality By Design In Pharmaceutical Tablet Development 7/30/2024

    Quality by Design (QbD) ensures efficiency and high standards in pharmaceutical tablet development. Explore how this proactive approach transforms manufacturing processes and enhances product quality.

  3. Doubling Up For Speed In Biomanufacturing 12/12/2025

    Accelerate drug development and reduce risk with parallel operations. Learn how leveraging CDMO partnerships while building internal capabilities can cut costs and speed your path to market.

  4. Advancing Cell Therapy Manufacturing: Rapid Sterility Testing 5/7/2024

    The rapid sterility test kit used in the study was able to quickly detect bacteria and fungi in complex cell therapy product matrices, detecting six species listed in USP chapter <71>.

  5. Strategic CMC Planning Through A Phase-Appropriate Quality Approach 5/28/2024

    A phase-appropriate quality approach ensures quality activities align with the unique risks and challenges of each development stage. Watch to learn how to apply such an approach to chemistry, manufacturing, and controls planning.

  6. EMPQ And Validation Support Services 2/21/2024

    A growing pharmaceutical/biotech company hired a global consulting firm for a project that required EMPQ services for qualification activities on a newly completed aseptic processing suite.

  7. Monitoring Microbial Contamination Of Mammalian Cell Cultures 2/21/2025

    Mammalian cells are widely used to produce complex processed molecules. Explore a system that effectively detects microbial contamination in mammalian cell cultures and utilizes a newly formulated lysis buffer.

  8. Inline Checkweighing Of Packaged Products In Manufacturing 12/29/2025

    Accurate inline checkweighing is vital for quality control. Learn how system design, software, and regulatory compliance work together to overcome high-speed production challenges.

  9. The Scalability Of Depth Filters For CHO Cell Culture Clarification 7/19/2024

    Clarification using depth filtration is standard in monoclonal antibody (mAb) manufacturing. Here, we showcase the scalability of Stax™ mAx depth filters, demonstrating their effectiveness.

  10. Leachables Method Development, Validation And Relevant ICH References 5/16/2025

    It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.