Industry Insights

  1. Stand By To Stand By: Organizational Contingency Planning 4/6/2020

    The coronavirus (COVID-19) pandemic has been a wakeup call, exposing the vulnerability of the global supply chain and the lack of emphasis placed on contingency planning.

     

  2. Developing A Process Performance Qualification Master Plan For Gene Therapies 4/19/2024

    This article provides considerations and a framework for a Process Performance Qualification Master Plan in the gene therapy industry. It is useful for sponsors with any level of experience.

  3. The 3 Phases of QRM – An Inspector's View 5/14/2025

    Quality resource management has three phases: assessment, control, and review. The experts at GMP Compliance Advisor bring us this breakdown of all of them.

  4. How To Choose A Sterile Connector

    Without a reliable connector, your batch could quickly be rendered worthless. Learn three considerations to give you confidence when selecting fluid handling connectors for your bio application.

  5. Formulation Is Key For Y-mAbs' Self-Assembling Antibody 5/16/2025

    The radiotherapy company's novel SADA construct uses self-assembling tetramers to deliver isotopes directly to cancer cells for a highly targeted, less toxic treatment.

  6. Mastering Upstream Development: Key Considerations For mAb Production 5/22/2024

    Selecting the right cell line is crucial in upstream development. Delve into key considerations that researchers and manufacturers must keep in mind to achieve high-quality and high-yield mAbs.

  7. Reliable Reportable Data With Analytical Quality By Design Approaches 1/27/2022

    In this blog we discuss how leveraging modern analytical tools and applying an Analytical Quality by Design approach in your lab can increase the robustness of analytical methods.

  8. Cleaning Up The Systems Mess: A Phased Approach To Implementing Real Automation And EBRS 5/20/2020

    The biopharma industry uses the most sophisticated microbiological and genomic technology, and we experience waves of advancements in therapies driven by our computing and communications technology. So, why are we still drowning in 100-page paper batch records, books of SOPs on the plant floor, and paper documents being handled by operators?

  9. The Regulatory Labyrinth Of Stem Cell Treatments 12/20/2022

    In August, Judge Bernal of the Central District of California ruled that stem cells that are removed from a patient, centrifuged, and reinjected into a patient are not “drugs” and therefore do not require FDA premarket approval. FDA filed a notice of appeal in October, but the appeals process will take time. Until then, the decision may have consequences for stem cell therapy companies.

  10. Tips For Deploying Advanced Modeling In Commercial Phase Bioprocessing 8/23/2024

    In-silico tools are ubiquitous in development, but big hurdles prevent them from showing up meaningfully in commercial manufacturing. These tips could help clear them.