Industry Insights

  1. Will Genome Modifications Define Next-Gen AAV Vectors? 5/20/2025

    AAV vectors composed of naturally occurring capsids are suboptimal. Gentle genetic alterations hold promise for safer, more efficient therapy.

  2. Understanding The FDA's KASA Framework 10/30/2019

    The FDA's Knowledge-Aided Assessment & Structured Application Framework marks an ambitious step forward in standardizing and increasing the efficiency of the drug review process. Here's what it will take for the framework to succeed. 

  3. Assembling The Package Integrity Profile For Autoinjectors

    Due to their complexity, combination products present unique challenges in implementing a container closure integrity (CCI) testing strategy. Learn about these challenges and how to overcome them.

  4. Quicker Development Using Cell Line Integration, End-To-End Support 6/19/2025

    Despite challenges with mammalian host cell line diversity, Lonza's mitigation strategies drive efficiency and reproducibility, maximizing cell growth and product quality.

  5. Navigating The Pros And Cons In Annex 1's PUPSIT Requirements 7/12/2023

    Annex 1 made Pre-use Post Sterilization Integrity Testing, or PUPSIT, a requirement, and enforcement has begun in earnest over the last few years. This article digs into the problems that downstream filter manipulation can cause and questions whether the risks outweigh any benefits.

  6. A Look At Elsa, The FDA's New AI Digital Assistant 6/12/2025

    The U.S. FDA recently launched its very own generative AI tool called Elsa. It's designed to assist FDA employees across various functions, from scientific reviewers to investigators.

  7. The Role Of Human Performance Tools & Just Culture In Biopharma Operations 1/20/2017

    The behavior of the people within an organization can be the least predictable part of the business. While the pharmaceutical and biotech industry has been successful in incorporating lean and Six Sigma principles to increase operational and system efficiency, there has been a lack of similar gain demonstrated when dealing with human behavior and human error.

  8. Coronavirus Outbreak: Manufacturing, Supply Chain Lessons Learned 3/11/2020

    The COVID-19 outbreak serves important lessons on supply chain integrity. While events like this are impossible to completely prepare for, safeguards can reduce timelines and shorten supply impacts.

  9. ADCs Are The Future Of Precision Chemotherapeutics 8/23/2022

    Antibody-drug conjugates (ADCs) allow potent chemotherapeutics to be targeted to their intended site of action and offer a wider therapeutic window compared to traditional systemic chemotherapy. This article delves into how ADCs provide targeted treatments and shares emerging trends in ADC development.

  10. Is It Ever Too Soon To Start Your Extractables And Leachables Assessment?

    Learn what you need to know about planning for your extractables and leachables testing programs to mitigate delays to your drug development timelines.