Industry Insights

  1. Optimizing Cell Line Development For Next Generation Biologics 8/21/2024

    CLD platforms must be flexible and efficient to accommodate increasingly complex molecules. Utilizing standardized, modular approaches, as well as strategic partnerships with CDMOs, can help.

  2. A Step Toward Using More Human-Relevant Models In Biomedical Research 3/10/2021

    Animal models are ineffective in predicting human response to many biologic medicines and vaccines and present ethical and geopolitical challenges. A paradigm shift is needed to improve drug discovery.

  3. Elevate Your T-Cell Manufacturing Process 2/15/2023

    Today automation and next-generation bioreactors are two prime areas of innovation for enhancing cell manufacturing. Here we delve into some ways these innovations could improve T-cell based therapy production.

  4. Renovating An Existing Biotech Plant To Accommodate A Higher-Titer Product 1/11/2018

    Today, a wide spectrum of plants are moving into their next generation of production of monoclonal antibodies (mAbs) and other therapeutic expressions. This new higher titer changes the way we look at both the process and the facility.

  5. A New Year's Resolution Suggestion For The FDA 1/22/2024

    Many pharma/biotech companies have continuing compliance problems when getting inspected by our friends at the FDA. In this article, this industry observer with almost 50 years of experience shares some New Year's resolution wishes for the FDA, and, by extension, industry members can consider the list as the foundation for sustainable quality in your operations.

  6. Advancing Immune Cell Therapies And Overcoming Cost Challenges 8/15/2024

    Immune cell therapies have incredible potential for cancer treatment, and making them more cost effective is a critical consideration for improving patient access and outcomes.

  7. Stable Bulk Cultures: A Fast Path To Antibody Manufacturing 7/25/2024

    The potential advantages that stable bulk cultures can offer a drug development paradigm are poised to accelerate and bolster biopharmaceutical clinical manufacturing.

  8. Calculating Cleaning Process Capability: Analysis Of Total Organic Carbon 1/10/2022

    This article will examine a data set of actual total organic carbon (TOC) swab data collected during cleaning validation for a pharmaceutical manufacturing facility and will show how much cleaning process knowledge and cleaning process understanding can be easily obtained through some simple statistical evaluations of such data.

  9. Rethinking Cancer Treatment With Anixa's Amit Kumar 8/18/2022

    Overcoming the hurdles of CAR-T therapy development for solid tumors will require novel science, innovative processing, and unshakeable optimism.

  10. Critical Considerations In Outsourcing Nanotechnology Drugs 3/27/2019

    If the mission statement of nanotechnology is “to perform precise interventions at the cellular or molecular level to improve health and promote quality of life,” then the contract manufacturer might seek a mission statement such as, “to enable novel therapy in a safe, effective way, advancing medical science one medicine at a time.”