Industry Insights

  1. Gamma, Ebeam Or X-Ray? The Future Of Radiation Sterilization 2/24/2022

    Explore insights into gamma, Ebeam, and X-ray sterilization modalities as well as comparative studies by leading academic and trade organizations and their conclusions drawn on sterilization techniques.

  2. What Are The Measurable Benefits Of Modern MES Software? 11/21/2022

    Even a small amount of paper on the factory floor carries hidden costs in impeded throughput, productivity, and on-time shipment. Explore the benefits of a modern MES software solution.

  3. Industry Trends In Biologic Formulations

    Major factors that are driving the market growth are next-generation business, high growth in chronic diseases, less expensive biosimilar drugs, and favorable government regulations.

  4. Selecting The Right pDNA Supplier: 10 Key Factors To Consider 3/13/2024

    Selecting the right pDNA supplier is a critical decision that can significantly impact the success of your project or research. Consider these 10 key factors to help you make an informed choice.

  5. Demystifying The Common Technical Document For Global Submissions 6/5/2025

    The CTD's Module 3 is notoriously complex and challenging. Here are strategies for an easier path toward CMC submission readiness.

  6. Calculating Process Capability Of Cleaning Processes With Completely Censored Data 10/31/2022

    Data below the detection limit (DL) are known as left-censored data. Quite often, 100% of the results of the cleaning samples fall below the DL. How can cleaning process capability be calculated in such situations? This article explores several approaches.

  7. Antibody Drug Conjugates (ADCs): Complex, Powerful Drugs Requiring Complex Analytical Solutions 12/22/2015

    In the past decade, much focus has been placed on developing more stable linkers and more potent cytotoxic payloads; these improved constructs have resulted in better therapeutic agents. In spite of these improvements, further optimization of linkage sites on the antibody, along with higher potency cytotoxins, better antigen selectivity, and improved cleavable and non-cleavable linkers have resulted in better, highly-targeted oncology drugs.

  8. Janssen v. Celltrion Federal Circuit Judgment: What Biosimilar Makers Need To Know 8/25/2020

    The Federal Circuit recently issued Rule 36 judgments in two separate BPCIA cases: Genentech v. Amgen and Janssen v. Celltrion. This two-part article series explores some of the unanswered questions raised in these two cases. In Part 1, Genentech v. Amgen was discussed. Here, Part 2 delves into the remaining questions following Janssen v. Celltrion.

  9. Closed-Loop Manufacturing Is The Cell Therapy Revolution We Need 6/18/2025

    In cell therapy manufacturing, automated closed systems with integrated software controls offer numerous benefits over traditional open systems.

  10. What To Do When Your Regulatory Findings Need Quality Risk Management Action 10/2/2024

    More than half of all recent warning letters issued by the FDA include citations for absent or incomplete risk assessments. This article examines what regulators are looking for.