Industry Insights

  1. An Introduction to Polymeric Materials for Medical Devices 1/11/2021

    What's the best utility of polymeric materials employed in healthcare and medical devices? Eric George, Ph.D., of ERG Polymers LLC discusses terminology and nomenclature, polymer structure and chemistry, and a process for material selection for specific applications, focusing on thermoplastics. And stay tuned for future follow-up articles that do a deep dive on polymers for coronary angioplasty, point-of-care testing and wearables, ophthalmic applications, and drug delivery!

  2. Reflecting Again On GMP Requirements For Marketing Authorization Holder 12/20/2023

    Learn in detail about Annex 16, the responsibilities of Marketing Authorization Holders (MAHs), and a practical way for MAHs to implement their responsibilities with their contract manufacturers.

  3. Quality Agreements, Tech Transfer & Risk Management In CGT 2/27/2026

    Early quality, strong tech transfer, solid data discipline, and risk‑based decisions help accelerate advanced therapy programs and ensure compliance, scalability, and regulatory confidence.

  4. Process Characterization: The Foundation For Validation 11/22/2019

    Process characterization is the foundation for process validation activities. Too often, validation activities fail due to the lack of process characterization using sound statistical and scientific methods, including design of experiments (DOE).

  5. How To Improve FDA Inspection Readiness & Outcomes By Mining Publicly Available Data 10/14/2020

    Now that we have years of real-world regulatory outcomes data available, why are we ignoring their power to serve as a corrective lens for our interpretations of the law?

  6. Gene Therapies For Better Kidney Treatments With Purespring Therapeutics 8/16/2022

    Purespring Therapeutics explores the importance of pursuing new treatments for kidney conditions and shares why it's poised for long-range commercial success.

  7. Embracing Robotics To Scale Cell And Gene Therapy Manufacturing 3/1/2023

    This article explains the robotics landscape, the difference between automation and robotics, as well as three steps to introduce robotics into your cell and gene therapy business.

  8. Ensuring Drug Accountability In Clinical Trials 10/1/2021

    Pharmaceutical companies and regulators can’t be assured the results of the trial are accurate if there’s information missing from the drug accountability record. Ensuring proper drug accountability is far from simple. It requires forethought and consistency to be done properly.

  9. The New EMA Protect ADR Database 3/26/2013

    On February 18, 2013 the EMA released a new Adverse Drug Reaction (ADR) database. By Bart Cobert

  10. Evaluation And Identification Of Subvisible Particulate Matter In Injections

    Review the scopes of USP chapters <787> and <788>. Both chapters address injections and have the same regulatory requirements according to their nominal volumes for subvisible PM.