Industry Insights

  1. Navigating Sterile Injectable CMO Selection: A Technical And Quality Assessment 6/11/2025

    Learn how to carry out an effective technical and quality assessment and what specific criteria to prioritize when selecting a sterile injectable CMO partner.

  2. Tips To Maintain Your Pharmaceutical Tablet Presses And Tooling 1/31/2023

    Implementing a cleaning procedure is essential to maintaining tablet tooling and presses. Clean tooling reduces product cross-contamination risk and decreases premature wear. 

  3. Ensuring The Efficacy Of Probiotic Products

    Without proper handling and packaging, the efficacy of probiotics can be compromised at any point in the packaging, storage, and transportation process, impacting shelf life and effectiveness.

  4. Getting The CAPA Framework Right The First Time 5/8/2024

    CAPA processes, though often seen as regulatory burdens, offer significant business benefits. Implementing them requires a cultural shift and methodical approach for lasting improvement.

  5. Speeding-Up Analysis And Fast-Tracking mRNA Development 5/13/2024

    mRNA therapeutics have the potential to address a variety of diseases, and understanding mRNA molecules and access faster analytical solutions are crucial elements for the rapid development of these therapies.

  6. Leveraging AI To Build Process Intelligence And Streamline Drug Development 4/4/2025

    Accelerate drug development with AI. Enhance process intelligence and achieve gold-standard data sets with the right digital tools and improved maturity.

  7. How Digitization Enables Safe, Connected Operations In Manufacturing 8/25/2021

    The global business disruption caused by COVID-19 has exposed weaknesses in manufacturing. In this article, we discuss some production challenges revealed by COVID-19, and reasons to digitize.

  8. Meeting The Challenge Of Delivering High-Volume Biologic Therapies 2/16/2021

    As the industry moves toward self-administration to reduce healthcare costs and improve patient convenience, there is a compelling need for simple-to-use, low-cost, disposable devices.

  9. How To Navigate Drug Repurposing And Bridging Studies 6/17/2022

    Rarely is a new drug the optimal version of that product, and drug companies often search for new uses, new users, or new dosage forms of an approved product after it hits the market in what is commonly known as “drug repurposing.” To receive FDA approval for a repurposed drug, companies must submit bridging studies that often include clinical trials. 

  10. How To Implement Proper Gowning Procedures In An OSD Facility 3/5/2015

    By Christine Hofnagel, AIA Associate, JacobsWyper Architects

    Within an oral solid dosage (OSD) Manufacturing facility, there are typically three levels of product exposure: general, protected, and controlled. Generally, the division of levels is directly related to the product or product component exposure, as well as to the physical environment and function within the facility. These levels vary as many manufacturing processes differ from site to site. The following article addresses specific gowning regulations for each of the three levels, as well as how to achieve them with a quality risk assessment program.