Industry Insights

  1. The Latest On CRISPR Deployment In TIL Therapy Development 5/30/2025

    Here’s a quick look at how CRISPR’s emerging as an enhancer to improve TIL pharmacokinetics, efficacy, and tolerability without disrupting production.

  2. Driving Compliance And Standardization In CGT Supply Chains 12/29/2025

    Standardization and compliance in CGT supply chains are critical for minimizing risk, ensuring product integrity, and meeting regulatory demands across global manufacturing and distribution networks.

  3. How Data Analytics Accelerates Transition To Bioprocessing 4.0 4/7/2023

    Following successful Industry 4.0 implementation in the automotive, communications, aerospace, and other industries, the biopharma industry is now joining the digital revolution.

  4. Overcoming AAV Manufacturing Challenges 5/20/2022

    Disruptive technologies and advances in analytics are needed to enable wider application of gene therapies in a cost effective and sustainable way.

  5. The Regulatory Labyrinth Of Stem Cell Treatments 12/20/2022

    In August, Judge Bernal of the Central District of California ruled that stem cells that are removed from a patient, centrifuged, and reinjected into a patient are not “drugs” and therefore do not require FDA premarket approval. FDA filed a notice of appeal in October, but the appeals process will take time. Until then, the decision may have consequences for stem cell therapy companies.

  6. A New Centre For Continuous mRNA Manufacturing 5/14/2024

    Explore how a partnership between academia, regulatory agencies, and manufacturing organizations has the potential to reshape the way we produce and distribute mRNA-based therapies.

  7. Avoiding ISO 14971 Mistakes — Do You Really Understand The Term “Hazard”? 1/13/2021

    Identification of hazards, hazardous situations, and harms is foundational to analyzing the risks associated with a medical device. Yet, these terms are often misunderstood and misapplied. This first part of a three-part video series reviews the term “hazard” in detail, highlights areas of confusion, and illustrates a few examples to facilitate a better understanding and its application in risk analysis. 

  8. Lessons Learned From Implementing FDA CSA Guidance 2/20/2024

    Explore how some drug manufacturers are using the latest Computer Software Assurance (CSA) guidance to reduce effort and cost and the bumps you may hit along the way.

  9. Integrating Advocacy Into The Cell & Gene Therapy Supply Chain 6/2/2021

    Treating advocacy as an institutional priority provides tangible benefits for Aldevron’s team members, our clients, and, most importantly, the patients waiting for these potential breakthroughs.

  10. Bacterial Endotoxin Testing, Part 1: Overview 7/16/2024

    All injectable drug products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins. This article provides an overview of bacterial endotoxin testing and the LAL method.