Industry Insights

1. FDA Leading The Decline Of Animal Testing 7/16/2025

   The gold standard practice of conducting animal studies for evaluating toxicity, pharmacodynamics, and immunogenicity is being challenged by innovative alternatives – New Approach Methods (NAMs).

2. A Flexible Mindset For Bridging Between Cell-Based Assay Groups 7/16/2025

   Transferring cell-based assays for biologics starts with defining operator and equipment parameters, positive and negative controls, and a sufficient dynamic range.

3. Advanced Manufacturing And CDMOs Are Rewriting The CGT Cost Equation 7/16/2025

   Without contract manufacturers, small biotechs often don't stand a chance of reaching commercial production scales, let alone global access for their drugs.

4. Exploring Outsourcing's Role In CGT Scalability And Affordability 7/16/2025

   CDMOs give therapy developers access to state-of-the-art production platforms and expertise without the massive up-front investment required for in-house manufacturing.

5. Redefining CGT With Exosomes And EVs 7/16/2025

   July’s Cell & Gene Live featured a comprehensive look at the scientific advances, clinical promise, manufacturing hurdles, and regulatory considerations shaping extracellular vesicle and exosome-based therapies. 

6. 4 Centralized Comparator Sourcing Models To Fortify Supply Chains 7/15/2025

   A team at Novartis developed models to address the often-overlooked challenge of clinical trial comparator sourcing, a weak link that can derail trials.

7. Essential Steps For A Successful Analytical Tech Transfer 7/14/2025

   Biologics tech transfer means sharing up to 20 assays. Miss a step, and you risk delays, bad data, and products stuck in limbo.

8. From Discovery To Delivery: Accelerating The Path Forward For Gene Therapies 7/11/2025

   We caught up with Lexeo Therapeutics’ Manny Otero, Ph.D., and Sandi See Tai, MD, to explore strategies to advance gene therapies.

9. Preparing For FDA's Expanded Use Of Unannounced Inspections At Foreign Manufacturing Facilities 7/10/2025

   The FDA announced on May 6, 2025, that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. Here are key considerations and actions to take in order to be prepared.

10. Pharma Enterprise Resource Planning: From Automation To AI-Driven Insights 7/10/2025

    Pharmaceutical firms are increasingly turning to enterprise resource planning (ERP) systems to modernize operations. These platforms unify core functions, including supply chain management, manufacturing, and financial planning and analysis.