Expert Insights On Cell Line Development

51. Qualifying Working Cell Bank Replenishment 9/6/2022

    Cell banks represent the fundamental starting substrates for biological drug substance/drug substance intermediate manufacturing. The availability of well-characterized cell banks is imperative to ensure drug product supply. This article shares regulatory tips for cell bank registration and regulatory considerations when replenishing a working cell bank.

52. The Environmental Impact Of Biopharma Continuous Manufacturing: Part II 8/22/2022

    Part 1 of this two-part series began to compare the environmental impact of biopharma continuous manufacturing with batch manufacturing. In this article, the author considers process efficiency, single-use technology, and facilities requirements.

53. The Environmental Impact Of Biopharma Continuous Manufacturing 8/8/2022

    One aspect of biopharma continuous manufacturing (BCM) often overlooked is its environmental impact compared to that of a similar batch process. In comparing the two, there is much that needs to be considered. This article is the first in a two-article series and discusses key considerations of both processes and provides a deep-dive into water usage.

54. AstraZeneca Implements A "Technology Uplift" Of Its Microbiology Labs 5/31/2022

    Modern microbiology labs are busy, with a wide range of activities taking place from final product testing to auxiliary support such as quality control release checks on nutrient media. While instruments and equipment available to technicians can vary, AstraZeneca wanted a networkwide approach to modernizing its labs.

55. 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.

56. 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.

57. 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.

58. 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?

59. 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.

60. 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.