Industry Insights

  1. Pursuing Venture Philanthropy With Opus Genetics: The Business Of Biotech 8/10/2022

    Explore new, more agile approaches to overcoming the advanced therapy obstacles inherent to bringing rare disease treatments to market.

  2. Upskilling Your Quality Team For The AI Revolution In Pharma 4.0 3/21/2025

    While AI systems offer advanced capabilities for data analysis, process optimization, and quality assessments, your quality team must first be proficient in interacting with them.

  3. 7 Key Concepts In The FDA's Quality System Guidance For Pharma 3/4/2022

    Here are some key concepts that the FDA deems critical for a discussion on modern quality systems and defines them within the scope of pharma manufacturing.

  4. Importance Of Process Safety In Fluid Management Of ADCs 11/22/2022

    Learn more about the application of ADCs, the challenges of manufacturing them, and tools for handling them in closed systems without exposing them to the environment.

  5. Are We Witnessing A New "Age Of The CDMO"? 12/3/2024

    Over the past few years, the pharma/biotech industry has seen a significant shift from internal to external manufacturing. This article examines the driving factors and the author's perspective for what to expect in 2025 and beyond.

  6. Trends In Bioprocessing CDMO Selection

    Learn which CDMO characteristics experienced outsourcers value most from ISR’s Bioprocessing Market Trends and Outsourcing Dynamics report.

  7. 5 Reasons To Move From Shake Flasks To A Bioreactor 11/14/2023

    Find out how a bench-scale bioreactor could pave your way to maximum culture density, better process information, and scale-up/scale-down development.

  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. Aiming To Solve The 3 Key Challenges Of CAR T-Cell Manufacturing 1/18/2022

    These authors share their best practices for solving the three key challenges of CAR T-cell manufacturing (supply constraints, scalability issues, and storage and logistics challenges) using their experiences with Epstein Barr Virus (EBV) T cells.

  10. Risk vs. Resilience: Striking A Balance In The Biopharma Supply Chain 4/5/2022

    What are the biggest vulnerabilities in today’s biopharmaceutical supply chain, and what can suppliers to do address them?