Industry Insights

1. Lessons In Quality From Sanofi's Plai.qa 11/24/2025

   The platform orchestrates data to evaluate site maturity and performance and provide recommendations for improvement.

2. What To Expect From Your First CMO Remote Audit

   Choosing the right manufacturing partner means going beyond just technical specs. Viewing the facility layouts and conditions is critical. Now is the time to familiarize yourself with remote auditing.

3. 3 Considerations When Developing Your LVV Program 12/3/2020

   If you are looking to get a lentiviral vector (LVV) program off the ground, selecting the right contract development and manufacturing organization (CDMO) partner can be a game-changer. Expertise, production and equipment are three key considerations you should evaluate to determine if a prospective CDMO is a fit for your LVV program’s needs.

4. Analysis Paralysis: Navigating Early-Phase Analytical Validation 3/31/2023

   Qualification’s reduced set of testing requirements aims to demonstrate a method is suitable for its intended purpose, but it typically is not as robust as method validation.

5. Manufacturing Interleukin-2 For In Vivo Use: Key Considerations 9/16/2025

   Interleukins help optimize therapeutic outcomes in cancer immunotherapy and regenerative medicine. Manufacturing success requires stringent control over production, formulation, and stability to ensure safety and efficacy.

6. Considerations For The Use Of Stable Producer Lines In The Manufacturing Of Lentiviral Vectors 11/24/2019

   There are many challenges with transfection-based protocols for producing LVVs at large scale. Here we will take a closer look at the use of stable producer cell lines as an alternative to transient transfection for the manufacture of LVVs.

7. What Time Is Best To Bring My CDMO On Board? 4/17/2024

   The answer might be sooner than you think and entail more transparency than you're used to.

8. PIC/S Annex Update: What Is Your ATMP Control Strategy? 6/30/2021

   Recently, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) revised Annex 2 of its GMP guide addressing the manufacturing of advanced therapy medicinal products (ATMPs). While this guide is not an FDA or EMA guidance, it represents the consensus thoughts of a group that those regulators participate in. 

9. The Importance Of Linear Scalability In Nanoparticle Processing 10/14/2025

   Learn how turbulent jet mixing enables linear scalability, guaranteeing consistent nanoparticle quality from research to commercial production and accelerating product timelines.

10. Quantifying Operational Excellence In The Life Science Industry: Part 1 8/3/2023

    To thrive in the tightly regulated and fiercely competitive life science industry, organizations must prioritize Operational Excellence (OpEx). Explore the concept of OpEx and gain insight into its impact.