Industry Insights

  1. How To Improve Sponsor–CMO Collaboration Around Digital Deviations 11/17/2025

    Digital strategies and standardized data models cut manual work, boost accuracy and speed of information sharing, and build trust between sponsors and CMOs.

  2. Enhance The Cost-Effectiveness Of Your cGMP Chemical Supply Chain 11/4/2022

    Learn more about inclusions for your total cost of ownership, calculations to consider for cGMP chemical supply chain TCO, and how one mid-size CDMO improved cGMP chemical supply by outsourcing.

  3. Emerging Technologies In The Delivery Of Proteins & Peptides 6/28/2021

    The limited ability to selectively deliver new drug molecules in the forms of peptides and proteins remains a significant challenge. Therefore, new materials and manufacturing techniques are emerging to meet the challenges associated with the formulation and delivery of biopharmaceuticals and pharmaceuticals.

  4. What Is A Technology Transfer And How To Ensure A Successful Transfer - Part 1 5/10/2016

    Current market conditions, as well as a myriad other factors, have increasingly prompted drug developers to establish complex supply chains to ensure the commercial-scale manufacture of the compounds they’ve created. Perhaps one of the most important links in any contemporary supply chain is the one between drug owners and the contract manufacturing organizations (CMOs) they partner with to ensure that supply will meet the demand for their therapies. When it comes to these relationships, success hinges on several critical factors, but chief among them involves getting a highly critical process right: the technology transfer.

  5. An Agile Approach To Regulatory Information Management System Transformation 6/20/2023

    Life sciences industry regulators have become increasingly focused on data-driven processes as a means of managing marketing authorization submissions. But this requires that your regulatory information management system (RIMS) upgrades are in a state of continuous evolution and are approached holistically. 

  6. An Analysis Of FDA's Recently Issued Gene Therapy Guidances 2/20/2020

    In this article, we'll examine key changes to FDA's six finalized draft guidance documents on its framework to advance gene therapy. We'll also review a new draft guidance on determining “sameness” of gene therapy products for orphan drug designation/exclusivity.

  7. Helping Pharma Manufacturers Overcome DSCSA Interoperability Pain Points 4/13/2020

    With the FDA guidance documents and requirements of the Drug Supply Chain Security Act still unfolding, there is a growing need for sectors in the supply chain to align on how to meet various aspects of the law.

  8. mRNA-Lipid Nanoparticles Circumvent Viral Vector Limitations 6/1/2022

    Both physical and chemical nonviral gene delivery systems for ex vivo genetic modification offer advantages over viral vectors, including smaller scale production and the low risk of immunogenicity.

  9. Your Most Pressing Tech Transfer Questions Answered 3/17/2025

    No two tech transfers are the same. To ensure success with yours, select a CDMO that will be astute in their onboarding analysis and commit to ongoing collaboration.

  10. Global Implications Of Zero Tariffs On Indian Pharma Exports To China 11/5/2025

    Discover the worldwide impacts of China’s zero-tariff policy on Indian pharmaceutical drugs.