Industry Insights

  1. The Power Of The Pool: Using Bulk Cultures For Clinical Trial Manufacturing 7/29/2024

    Stable bulk cultures, made highly uniform using transposase-mediated technologies, may be the key to expediting clone selection for many biopharmaceutical applications.

  2. Leveraging 505(b)(2): Real-World Evidence Rescues Program 8/8/2022

    Discover how a biotech company that couldn't afford the time and expense of conducting studies recommended by another consultant got assistance for FDA approval.

  3. Bispecific Antibodies: Navigating From Design To Market Success 8/1/2024

    The design of bispecific antibodies requires a comprehensive assessment that takes the following aspects into account: half-life, mechanism of action, and manufacturing challenges like impurities and low yield.

  4. 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.

  5. Slide Down The Funnel To Stand Out 6/21/2023

    Explore the tremendous value of understanding brand position in the biopharmaceutical market and how research into strategic placement, target audience, and more can help companies stand out.

  6. Could Halting Cancer Cell Motility Stop Metastasis In Its Tracks? 1/5/2022

    Learn how 3D models could fill knowledge gaps in many areas, including those studying the role of cell motility in how cancer spreads.

  7. Container Closure Integrity Testing Strategies For Gene Therapies 6/7/2023

    Container closure integrity testing (CCIT) has been recognized as having a significant impact on batch yield. This article provides perspectives on CCIT strategies to minimize the impact on gene therapy drug product batch yield by examining recent industry survey results as well as best practices.

  8. Cell & Gene Therapy Bioprocessing: Demand For Better Process Control, Expertise & CMOs 5/14/2021

    Manufacturing capacity for both cell therapies and gene therapy viral vectors remains in short supply. From BioPlan Associates, Inc.'s new survey of biopharmaceutical manufacturing professionals, there is a current and worsening capacity crunch. The industry continues to demand innovative solutions from its suppliers in key areas that can be slow to develop. 

  9. Helpful Biosafety Testing Innovations Where And When You Need Them 4/24/2025

    Monoclonal antibody manufacturing is advancing to boost efficiency, cut costs, and expand access, driven by innovation, demand, and the rise of biosimilars.

  10. Equipment Validation In The Pharmaceutical Industry 12/17/2024

    Equipment validation ensures pharmaceutical equipment meets regulatory and quality standards. Explore how a structured process ensures compliance, reliability, and high product quality.