Industry Insights

  1. Solving Human Error Deviations In Pharmaceutical Manufacturing 4/15/2021

    As we study human error trends in our organizations, what does it take to uncover and address those organizational or cultural issues that are often at the root?

  2. Pharmaceutical Serialization: Is Your Data Management System Ready? 5/10/2017

    The FDA’s intent to not enforce the requirements of the Drug Supply Chain Security Act until November 2018 offered an additional year meet compliance. The deadline for that grace period is now!

  3. Validate Cryopreservation As A Defined Input, Not A Variable 4/28/2026

    Treating cryopreservation as a validated, controlled input improves consistency, quality, and patient outcomes by reducing variability across cell therapy manufacturing, storage, and distribution.

  4. Manual Assembly Strategies For Early‑Phase Combination Product Supply 2/12/2026

    Early‑phase combination products rely on manual assembly. Clear process design, quality controls, and collaboration help clinical supply teams reduce risk and maintain trial‑ready flexibility.

  5. Liquid Biopsy: Market Drivers And Obstacles 1/21/2019

    This article examines present and near-term opportunities for liquid biopsy, as well as what’s needed to elevate this innovative diagnostic tool to a standard of care.

  6. 6 Must-Haves For A Quality Management System (QMS) 9/20/2024

    Not every quality management system (QMS) has the same capabilities and connectivity. Review several features to take into consideration when selecting a QMS system for your organization.

  7. Ensuring A Successful Technology Transfer

    Manufacturing at scale requires adherence to established, scale-dependent process parameters and close examination of product characteristics and quality attributes. Learn the key considerations when preparing to move products from small-scale to large-scale production.

  8. Lessons From An Outsourced Validation Project That Came Off The Rails 7/24/2020

    I was recently hired by a sponsor company to support initiatives related to computer system, IT validation, and automation system validation. This article discusses my experiences and perspectives on this engagement, including best practices and lessons learned that other life sciences sponsor companies can apply in their interactions with their consultants.

  9. De-Risking Production Of Complex Oral Solid Dosages: Considerations & Key Capabilities 7/13/2026

    Reduce formulation and scale-up risk with integrated development and manufacturing expertise for complex OSD products.

  10. How Lipid Nanoparticles Overcome Solubility Challenges 3/7/2023

    More than 80% of NCEs are poorly soluble compounds. Overcoming this challenge using lipid nanoparticles is essential to move your drug product through the pipeline and into the market.