Expert Insights On Cell Line Development

51. Making An Unapprovable Drug Product Approvable: Lessons Learned 5/27/2022

    This true story explores a drug product that was in the middle of Phase 3 trials, generating the keen interest of the FDA, but which suffered a commercialization setback due to manufacturing inefficiency and safety concerns. They asked us to think about how we would transform the manufacturing process into a licensable process.

52. Biopharma In China: The Emerging Global Force Of Domestic Suppliers 5/23/2022

    Though multinational corporation vendors have seen double-digit pandemic-related sales increases for bioprocessing supplies in China, the top domestic vendors have posted even higher growth rates. With domestic supplier prices significantly cheaper, quite a few Chinese biopharma companies are shifting their purchase of supplies.

53. Key Considerations For Decarbonizing Your Biotech Facility 5/4/2022

    Biopharmaceutical manufacturing processes do not directly utilize fossil fuels, but fossil fuels are used in the generation of raw materials, consumables, packaging, and in supplying energy to building systems and manufacturing equipment. This article looks at key facility decarbonizing considerations using a case study with quantification of estimated costs.

54. The 13-Step Guide For Conducting Cell & Gene Therapy EHS Risk Assessments 3/14/2022

    One of the hurdles for cell and gene therapy manufacturers is the lack of health and safety guidelines. This article summarizes the main steps in a suggested EHS risk assessment process. It can form the basis for discussions between a contract manufacturer and client or between production and development departments. What could go wrong?

55. 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 18^th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production.

56. 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.

57. 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?

58. 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.

59. 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.

60. 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.