Articles, App Notes, Case Studies, & White Papers

  1. Developmental Testing Of IV Solutions 2/10/2022

    As IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration.

  2. Distributing Clinical Supply In The EU For Compassionate Use Programs 12/21/2022

    Explore the logistical and distribution risk management factors that need to be considered when planning an EU Compassionate Use Program, especially when faced with COVID-19 closures and challenges.

  3. Adapting Drug Supply Strategies To Modern Study Models 7/15/2024

    Advancements like remote-access drug refrigerators and smart packaging highlight the need for patient-centric trial models that integrate virtual and site-based activities to meet diverse patient needs.

  4. Outlook 2025: Key Trends & Insights 2/19/2025

    Dive into the key trends and challenges shaping the year ahead, from geopolitical uncertainties to cutting-edge innovation in AI, oncology, and weight-loss therapies.

  5. Creating Accurate, Efficient, And Effective CDMO Project Proposals 8/15/2023

    To receive the most comprehensive project proposal possible, it is important to fill out any questionnaire as accurately and completely as possible.

  6. Trade Compliance: Challenges In Global Biopharma Materials Logistics

    Have you noticed that it has become increasingly difficult to transport your material into and out of the United States? That’s because it has!

  7. Managing Refrigerated vs. Frozen Drug Product: What's The Big Deal?

    The most common storage is ultra-low temperature storage, but the fastest-growing is cryogenic, in vapor phase liquid nitrogen. This transition is huge. Chain of temperature and custody data is imperative.  

  8. Is Your Clinical Supply Strategy Ready For EU CTR? 3/3/2022

    One of the most significant changes in the new EU regulation is Annex VI, which covers changes in the labelling requirements for investigational medical products (IMPs). So, what are the implications of these changes and how will they affect outer immediate packaging? 

  9. Key Considerations For Emerging Companies When Selecting Packaging Components

    Recognizing the importance of packaging development and prioritizing its role in drug development early on can help proactively identify potential delays and overcome risks.

  10. Storing Biologics At Non-Traditional Temperatures

    Due to the complexity and temperature sensitivity of biologics, we're seeing an increase in non-traditional storage temperature requests. Here, we explore why this is occurring and the associated challenges.