Industry Insights

  1. Best Practices To Adapt And Improve Quality Control Programs For CGTs 5/8/2024

    Cell and gene therapies require adaptive and advanced assays for characterization and safety assessments, and assays historically used for biologics must diversify to accommodate them.

  2. Leveraging AI In Drug Discovery To Treat MS & Other Autoimmune Diseases 5/17/2023

    The advancement of artificial intelligence and machine learning algorithms means we can use large pools of genetic data to identify potential risk factors and disease-causing genes for multiple sclerosis and other autoimmune diseases. This author shares a three-pronged approach to analyzing data for AI algorithms, pitfalls to avoid, and AI for silico modeling.

  3. Top Challenges In Recombinant Protein Purification Process Development 3/27/2024

    Get insights from process developers working with recombinant proteins that cannot be purified with affinity chromatography.

  4. Key Considerations When Evaluating Bioprocess Bag Chambers 8/2/2023

    Explore considerations in the selection process of choosing a bag chamber according to E3051 that ensures optimal performance for application and user requirements.

  5. Building A Culture Of Compliance: The Life Sciences Path 2/4/2025

    Here, we explore the key elements of a robust compliance culture, including leadership commitment, clear policies and procedures, and employee empowerment.

  6. Unlock The True Potential Of Project Management: Power Skills 12/20/2023

    In today's fast-paced and ever-changing world of project management, technical expertise alone is no longer enough. Discover the true difference-maker propelling project managers to new heights.

  7. First In Line: FDA Vs. EMA Biopharma Approval Times 1/20/2021

    The majority of biopharma companies place the most emphasis on the U.S. market as the pillar of their business case and commercial strategy, but should they? This article reviews data from more than 200 new therapeutics approved by the FDA over the past five years to determine if there really is a difference in approval timelines between the FDA and EMA.

  8. What Global Survey Says About Scant Patient Access To CAR-T Therapy 6/17/2025

    The Worldwide Network for Blood and Marrow Transplantation initiated a survey to understand cost, infrastructure, and regulatory differences affecting access.

  9. What's The Role Of Intuition When Making QRM Decisions? 2/28/2022

    In Part 1 of this 2-part series, this author explained how to effectively set up your quality risk management (QRM) program for pharma and medical devices. In this article, he explains how to implement that program. For such a numbers-based field, there is still an important role for using your intuition to make QRM decisions.

  10. Assessing CT-P13 SC's Impact Across Indications 3/24/2021

    This is the second article in a two-part series exploring the anticipated competitive dynamics for Celltrion’s subcutaneous (SC) infliximab bio-better, CT-P13 SC, in the U.S.The author explores how market dynamics across different autoimmune indications will drive distinct uptake of CT-P13 SC, highlighting the potential impact on TNF inhibitor competition.