Expert Insights On Cell Line Development

  1. 2021's Bioprocessing Year In Review And 7 Key Takeaways 1/11/2022

    The biopharma industry has responded aggressively and effectively to the COVID-19 pandemic. However, supply chain challenges, shortages, hiring problems, and regionalization have created the need for new strategies. Explore more in BioPlan Associates’ 2021 18th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production.

  2. Model-Based Control In Continuous Biomanufacturing 11/24/2021

    In comparison to batch manufacturing, continuous manufacturing offers shorter development time, improved product quality, lower capital cost, and easy scale-up. The primary focus lies on establishing a flexible and standard platform with real-time monitoring, automated start-up/shut down, and a control strategy to address dynamic conditions.

  3. Juno v. Kite: Implications For Functionally Claimed Biologics 11/12/2021

    The Federal Circuit recently reversed a jury verdict in the case Juno Therapeutics, Inc. v. Kite Pharma, Inc.., wiping out a $1.2 billion judgment for Juno in the lower court by invalidating claims directed to the functional properties of biological compounds that could be used as therapies. What does this mean for biologics developers going forward?

  4. How To Mitigate The Risks Posed By "High-Risk" Host Cell Proteins 11/3/2021

    Host cell proteins are process‐related impurities that may copurify with biopharma drug products. Some of these can be considered high-risk, including those that are immunogenic, biologically active, or enzymatically active with the potential to degrade molecules or excipients used in formulation. Here's how to mitigate those risks.

  5. Where Is Technological Innovation Needed For CAR-T Manufacturing? 10/29/2021

    Investment in cell therapy biomanufacturing has continued to follow a steady upward trend. Even with the anticipated increases in capacity, there are still concerns facing current and future cell therapy manufacturing capacities, including an anticipated “capacity crunch.” This article examines where technological innovation is needed to avoid this capacity crunch.

  6. COVID-19 Spurs Growth Of China's Domestic Bioprocessing Suppliers 10/8/2021

    Just as the U.S. and European bioprocessing supply systems have seen more robust growth than ever before, China’s domestic demands for single-use bags, cell culture media, and purification resins are all on the rise. BioPlan’s Top1000Bio database of global bioprocessing facilities has tracked industry capacity and employment growth over 15 years. 

  7. Biotech Patenting: 4 Tips & Personal Experiences 9/13/2021

    When you file for patent protection for your discoveries, keep these 4 tips in mind. I also share some of my personal experiences with patenting from over the course of the last 28 years, from when I cofounded 180 Life Sciences through now.

  8. Vaccine Manufacturing: Harnessing Lab Deviations 9/8/2021

    For National Immunization Awareness Month, we're highlighting timely vaccine manufacturing-centric content such as this from Tunnell Consulting's Bob Johnson. The presence of deviations may seem inevitable, yet COVID has brought to light the question of how vaccine manufacturing sites can manufacture more vaccines, more efficiently. This article explains how.

  9. How To Find & Manage Biotech Consultants Effectively 9/6/2021

    The roles being filled by biotech consultants have grown considerably, as companies are becoming more familiar with working with consultants and more people are interested in pursuing a consultant career. But how do we find good consultants, and how do we ensure that our consultants are as committed and engaged as our full-time employees? Here's how to accomplish that.

  10. What's The Role Of Interim Consultants In The Life Sciences & How Do We Use Them Effectively? 9/3/2021

    When life sciences companies need new talent, they typically have two options: bring in a consultant or hire a full-time employee. Usually, this decision is dictated by the permanence of the role, but sometimes, timelines complicate things. In this situation, an interim consultant can be the solution. But what is the interim consultant's role, really, and how do we use them effectively?