Material Handling Featured Articles

  1. Nitrosamines: New WHO Guidance Provides Expanded Risk Assessment Considerations 5/6/2024

    Nitrosamines are potential contaminants of drug products. Contamination can occur from synthesizing APIs and excipients, from leaching into the product from primary packaging, and more.

  2. Quality Imperatives In Oral Solid Dosage Manufacturing: An Overview 5/2/2024

    This article overviews the critical aspects of OSD manufacturing and the importance of understanding and implementing regulatory guidelines within the context of quality.

  3. Navigating OSD Formulation Development And Leveraging CDMO Partnership 4/17/2024

    Collaborating with an experienced CDMO can provide the expertise and facilities needed to navigate oral solid dose formulation complexities and ensure compliance with regulatory frameworks.

  4. Pharmaceutical Solid-State Studies 4/9/2024

    Solid-state characterization meticulously analyzes the physical properties of a drug in its solid form. Understand how this analysis is integrated throughout the drug development lifecycle.

  5. Process Development With “The End In Mind” For Startups 3/20/2024

    We encounter the term “the end in mind” in product development frequently, but many are unsure what it really means and when it matters. This article sheds light.

  6. 2024 LIMS Trends 3/15/2024

    The laboratory information management system (LIMS) landscape in 2024 is a dynamic one, driven by accelerating advancements in technology and evolving industry needs. This article shares the four key trends.

  7. A Solvent-Free, Fusion-Based ASD Manufacturing Process 3/5/2024

    Explore a solvent-free alternative for the production of amorphous solid dispersions (ASDs) that not only improves manufacturability but also reduces the carbon footprint of ASD manufacturing.

  8. Early Development Considerations For NCE Success: Quality Systems 3/1/2024

    Leveraging robust quality systems can improve efficiency throughout the product development lifecycle and help companies avoid unnecessary knowledge and tech transfer, saving both time and cost.

  9. Modified Release Formulations: Extending Drug Commercial Lifecycle 3/1/2024

    A CDMO with expertise in modified-release dosage forms can provide valuable assistance in formulation development, processing considerations, analytical challenges, and regulatory requirements.

  10. Assessing Cross Contamination Using Layers Of Protection Analysis For Facility And Product Safety 2/14/2024

    Layers of protection analysis (LOPA) is a risk tool that focuses on the strength of controls that are currently in place and enables a cross-functional team to dive into the ways that the controls may fail. The article outlines the application of LOPA to drug product and facility cross contamination.