Industry Insights

  1. 3D Printing For Pharmaceuticals & Medical Devices: A Primer With Risk Considerations 1/28/2022

    Implementation of single-use technologies for pharma and medical device manufacturing has introduced advantages in terms of design, sterility assurance, and a reduction in energy usage. 3D printing can deliver precise measurements to production facilities. This article describes the 3D printing process, risk considerations, and limitations — but the future is bright.

  2. Your Drug Or Mine? Managing Drug Delivery Device Differentiation Hazards 5/13/2020

    To ensure that patients receive the correct product and medication dosage and to minimize the potential for medication error, drug delivery devices must be designed both to be differentiable from similar products and also to facilitate distinguishability between varying doses of the same medication.

  3. Limulus Amebocyte Lysate Test Using Chromogenic Methods Of Endotoxin Detection

    The bacterial endotoxin detection method using Limulus Amebocyte Lysate (LAL) was developed in the 1960s. Since then, it has served as a highly useful tool in both research and industry. Since the beginning of the century, it was known that the hemolymph of the crab Limulus Polyphemus went through a process of coagulation. By Lisa Komski, M.T., ASCP Senior Manager, Export And LAL; Wako Chemicals USA

  4. The Power Of A Platform Process For Lentiviral Vectors 5/29/2025

    A robust platform process can help ensure therapeutic efficacy and supply chain security for LVV-based products, as well as support aggressive development and commercialization timelines.

  5. Best Practices To Ensure Quality Of Raw Materials Used To Manufacture Therapeutic Proteins 8/25/2021

    Across biologics, raw material quality is a key driver of product quality and consistency. This article recaps a recent U.S. Pharmacopeia (USP) workshop on the subject, including recaps of best practices and experiences shared by the FDA, Merck, Biogen, and more.

  6. Scaling Up The Learning Curve For Large-Scale AAV Manufacturing 7/26/2024

    The complexity of manufacturing AAV products, coupled with the challenges linked to controlling their costs, underscore the importance of improving the efficiency and scalability of these processes.

  7. Data-Driven Approach Optimizes Robust, Scalable Lyophilization Process

    Selecting the right manufacturing partner with appropriate lyophilization expertise, experience, and analytical capabilities can speed drug development and expedite time to market for lyophilized drugs.

  8. Achieving Ophthalmic Production 5/23/2024

    A partner with state-of-the-art facilities can guarantee efficient and scalable production of ophthalmic solutions, drops, and ointments, and is critical as you navigate the complexities of ophthalmic production.

  9. Design And Packaging Advantages For Cell And Gene Therapy Drugs 9/3/2024

    With the increasing demand for cell and gene therapies, Crystal Zenith nested vials can help the biopharma industry overcome the challenges of scaling up manufacturing and logistics.

  10. The US Drug Pricing System Needs to Be Fixed 6/16/2021

    Reforms to the U.S. drug pricing environment are required, but to improve patients’ health outcomes, reforms must be grounded in a comprehensive understanding of the current drug pricing system. Otherwise, policymakers will make things worse, not better.