Industry Insights

  1. The Importance Of Planning When Implementing New Manufacturing Equipment 2/2/2023

    Many organizations miss the mark when developing proper equipment requirements documentation and realistic project timelines. Learn how taking time during the planning phase can save time in the end.

  2. Clinical Research Considerations For Rare Disease Patients: Part 2 — The Impact Of Physician And Site Support 12/12/2022

    Our industry must examine whether — and how — we support physicians and clinical trial sites, who work under constant pressure related to timelines, data quality, and patient care.

     

  3. Quality Without Compromise: GMP Annex 1 For Sterile Manufacturing 2/4/2025

    Annex 1 sets EU regulatory standards for sterile manufacturing, which emphasize contamination control, quality management, and risk prevention to enhance patient safety and regulatory compliance globally.

  4. It's About Time! Automate Biomolecule LC-MS Spectral Deconvolution 5/16/2022

    We detail the approach we’ve taken to not only speed up the processing of macromolecule electrospray MS data but to build smarter deconvolution workflows.

  5. Experimental λ-Carrageenan-Induced Inflammatory Pain Model For Testing Novel Analgesics 5/13/2025

    Explore reliable and reproducible λ-Carrageenan-induced inflammatory pain models for effective preclinical screening of promising analgesic candidates targeting chronic pain.

  6. Tim Freeman Series On The Powder Testing Toolkit 1/23/2012
    The pharmaceutical industry is currently undergoing a seismic shift in terms of manufacturing practice. The advent of Quality by Design and the Process Analytical Technology (PAT) initiative invite the adoption of smarter ways of manufacturing, and the engineering of more efficient processes that consistently produce materials of the necessary quality.
  7. Facility Design For OSD Continuous Manufacturing 12/29/2022

    Facility design for continuous manufacturing of oral solid dose (OSD) drugs differs significantly from design of facilities dedicated to batch processing. The primary differences reside within the facility layout, in terms of consolidation of unit operations, utility sizing, and limited manual process involvement, which minimizes the number of required personnel.

  8. Benefit From Leveraging Perfusion Early In Process Development 4/5/2024

    By addressing the complex needs of cell culture from the start, organizations can take steps to optimize their process, ensuring they are maximizing productivity and product quality.

  9. Are These 5 Misconceptions Keeping You From Modernizing QC? 10/15/2024

    Explore common misconceptions that obstruct progress and why overcoming these barriers early provides a competitive edge when preparing for commercialization.

  10. Juno v. Kite: Implications For Functionally Claimed Biologics 11/12/2021

    The Federal Circuit recently reversed a jury verdict in the case Juno Therapeutics, Inc. v. Kite Pharma, Inc.., wiping out a $1.2 billion judgment for Juno in the lower court by invalidating claims directed to the functional properties of biological compounds that could be used as therapies. What does this mean for biologics developers going forward?