Industry Insights

  1. Trends And Benefits Of Lean Manufacturing In Pharmaceutical Injectable Facilities 8/4/2025

    The pharmaceutical injectable manufacturing sector is experiencing unprecedented transformation through lean manufacturing adoption. This analysis examines current implementation trends, productivity impacts, and quality integration strategies based on data from leading pharmaceutical organizations.

  2. EMA Issues Draft Reflection Paper On Accelerating Biosimilar Approval 5/5/2025

    In April, the European Medicines Agency issued a draft of a new guidance document titled Reflection paper on a tailored clinical approach in biosimilar development. The public consultation runs until Sept. 30, 2025.

  3. Addressing Gaps In Cystic Fibrosis Treatment: Fixing Nonsense Mutations 8/8/2023

    Examine how the world’s largest and most diverse collection of novel RGNs and deaminases is increasing the potential for addressing the needs of CF patients with nonsense mutations.

  4. Scaling Personalized Medicines For Flexible Aseptic Filling 2/14/2024

    Traditional aseptic filling solutions can introduce contamination and variability. Learn about Cytiva's commitment to finding innovative solutions and improving patient outcomes in the field of medicine.

  5. Navigating The Pros And Cons In Annex 1's PUPSIT Requirements 7/12/2023

    Annex 1 made Pre-use Post Sterilization Integrity Testing, or PUPSIT, a requirement, and enforcement has begun in earnest over the last few years. This article digs into the problems that downstream filter manipulation can cause and questions whether the risks outweigh any benefits.

  6. Advancements In Ophthalmic Drug Manufacturing: Precision And Scale

    Learn how a CDMO partner that leverages a multidisciplinary team approach can help you achieve effective scale-up production, handle potent compounds, and ensure regulatory compliance.

  7. System Failure Mode & Effects Analysis (SFMEA): An Alternative Approach For Analyzing Risks 6/26/2024

    Your company likely uses risk matrices and FMEA for analyzing risks. This article describes an alternative approach for conducting a system failure mode & effects analysis.

  8. When Single-Use Technology Becomes An Economic Imperative 9/3/2025

    Industry changes increasingly favor SUT for novel products, even while stainless steel remains an essential part of many process trains.

  9. Strengthening Shop-Floor QA From The Ground Up 2/24/2025

    Quality is created where and when manufacturing happens, not later through inspection. This approach integrates the QA function into daily production operations.

  10. The 'Champagne' Of Human Umbilical Cord Cells? 2/23/2023

    Learn about a novel method to obtain unique HUCPVs and how premium quality hUC-MSCs drive innovative translational research.