Industry Insights

41. 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.

42. The Future Of Gene Therapy Logistics – A Pivotal Moment 2/4/2025

    Ensure the safe, reliable, and future-ready delivery of gene therapies with cutting-edge temperature-controlled logistics solutions.

43. A Robust Extractables Data Package Helps Drive Patient Safety 10/1/2024

    Complex drug product formulations are more common, so it is imperative to have a deeper knowledge of extractables to understand risks associated with potential interactions between packaging and product.

44. The Continuation Of A Journey 8/19/2025

    See how one family managed to get an investigational gene replacement therapy manufactured and approved by the FDA so their daughter could be dosed just 14 months from her diagnosis.

45. 1 More Year For DSCSA Prep: Pros, Cons, & What To Do Next 10/30/2023

    The FDA recently announced that they do not intend to take action to enforce drug distribution security requirements under section 82(g)(1) of the FD&C Act until Nov. 27, 2024. What are the pros and cons of this announcement, and what should we do now? This expert shares his perspective and recommendations.

46. Integrated In Silico, Lab Assessments For Faster Drug Development 1/21/2026

    Integrated in‑silico and lab developability assessments flag molecular risks early, improving formulatability, manufacturability, and stability while reducing late‑stage failures, costs, and timelines.

47. Trends In FDA Quality System Inspections: 3 Takeaways To Ensure Future Success 3/17/2021

    Each year, the FDA performs inspections of medical device quality systems for products planned for or already on the U.S. commercial marketplace and publishes summaries of the inspection observations. This article presents background and high-level observations on the inspection data over time, revealing 3 key takeaways.

48. Chugai's Race To Zero Emissions At UK4 In Tokyo 6/21/2024

    Chugai's sustainable model led the construction of a new DS/DP manufacturing site, UK4, in Tokyo. The company focused on eliminating three key emissions sources.

49. Applying Aseptic Practices To Protect Yourself From COVID-19 4/20/2020

    During this COVID-19 pandemic, we have all heard it: Wash your hands with soap and water for at least 20 seconds. This article focuses on transferring basic aseptic techniques and good hygiene practices learned in the pharmaceutical industry to help you dodge the COVID-19 bullet.

50. What Biotech Startups Need To Know About Sterile Fill Finish Services 2/24/2026

    Sterile fill–finish is a critical, tightly regulated stage for biotechs, demanding strong contamination control, smart CDMO selection, and awareness of capacity, scalability, and regulatory hurdles.