Industry Insights

1. Notes From A VC: What It Takes To Be Impactful In Longevity Science 11/6/2025

   Impact in longevity science (particularly for cell and gene therapies) is not about chasing the next unicorn; it is about carrying transformative ideas across the threshold of scientific validation, regulatory trust, and societal acceptance.

2. A Multi-Omics Approach For Characterizing Clinical-Scale iPSC Batches 11/6/2025

   The transition from 2D to 3D cell culture requires a combination of advanced analytical techniques, but aligning new methods with established principles can be challenging.

3. Global Implications Of Zero Tariffs On Indian Pharma Exports To China 11/5/2025

   Discover the worldwide impacts of China’s zero-tariff policy on Indian pharmaceutical drugs.

4. Why Do So Few Cell Therapies Make The Leap From Lab To GMP? 11/5/2025

   Among other reasons, academic centers have access to sophisticated technology. In contrast, manufacturing suites must use established, validated methods.

5. Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots 10/31/2025

   The terms “confirmatory" and "conformance" batches are inconsistently used in the industry. Since process validation is essential for maintaining compliance and detecting variability, we must work toward harmonization of the terms to avoid confusion.

6. Are You Still Evaluating CMOs When You Really Need A CDMO? 10/29/2025

   Outsourcing adds capacity and specialized knowledge to your supply chain. But contractors come in several types. Here's how to pick the right one.

7. How Early Manufacturing Decisions Shape Long-Term Success 10/27/2025

   Early manufacturing choices in cell and gene therapy shape long-term clinical and commercial success, so leaders from Allogene and Verismo emphasized that both autologous and allogeneic developers should prioritize process simplicity, risk-based decision-making, and adaptable manufacturing as therapies move from concept to clinic.

8. Here's A Thought: What If Gene Editing Didn't Use Bacterial Enzymes? 10/27/2025

   Citing the dismally few wins for CRISPR/Cas9 and other gene editing systems, one scientist proposes delivering zinc finger DNA-binding peptides using AAV6 vectors.

9. Analyzing CAR-T Surface Proteins With Immunoprecipitation Coupled With Mass Spectrometry 10/24/2025

   Among other benefits, the approach can help compare CAR constructs, evaluate the effects of manufacturing processes, and monitor changes in protein interactions.

10. Regulatory Pathways — With Real-Life Examples — For Successful CGT Clinical Trials 10/24/2025

    Discover the most effective regulatory pathways used to support CGT development, including two real-life examples.