Industry Insights

51. 7 Improvements in Clinical Supply Chain Management Your CFO Will Love 10/2/2023

    There is a great opportunity for clinical supply chain practitioners to learn from their commercial peers. By adapting and adopting the right commercial best practices, clinical supply chains become more effective, cost-efficient, and agile in delivering the right treatments to the right patients.

52. How To Accelerate Thermal Stability Testing For High-Concentration Drugs 10/3/2024

    Discover an innovation that addresses a crucial need in antibody formulation development by enabling rapid, high-throughput thermal stability testing at formulation-strength concentrations.

53. Set Up A Single Use System For Success And Flexibility 5/22/2023

    Achieve manufacturing operational flexibility, ease compliance, and get to market faster with modern distributed control systems and the incorporation of single-use systems.

54. The Ideal Quality Management System For Packaging And Printing 10/29/2018

    Quality management systems come in many shapes and sizes. Each is largely dependent on the industry to which a given application caters. There are nevertheless basic standards that must be met.

55. Impact Of JCA And Project Orbis On The European Revenue Potential Of An Oncology Product 6/12/2025

    Contrary to concerns about price erosion, new analysis suggests Joint Clinical Assessment and Project Orbis will likely increase European oncology product revenue by enabling faster market uptake.

56. How To Avoid Form 483s For Biopharma Software Validation Failures 8/17/2022

    The FDA will issue a Form 483 for noncompliance in the software validation GxP environment, mostly due to data integrity failures, inadequate written procedures, deficiencies in investigations, and substandard laboratory controls.

57. Third Principle Of Green Chemistry: Less Hazardous Chemical Syntheses 11/26/2024

    Chemists and chemical engineers must prioritize sustainable practices by innovating holistic, efficient processes that minimize environmental impact and toxicity, addressing challenges like solvent waste and complex molecule synthesis.

58. Fundamentals For Bispecific Antibody-Based Cell Line Development

    BsAbs’ dual specificity opens a wide range of applications. Understand why consistent production of structurally complex molecules that exhibit high yield and purity requires keen expertise and experience.

59. Will The Tablet Hold Together Until It Reaches The Customer?

    R&D selects the active ingredients for a tablet to make sure that it fulfills its primary mission of helping customers overcome a particular ailment.  Qualifying the tablet involves making sure that physical properties, like strength and dissolution rate, are appropriate.  Texture Analyzers have come into prominence providing an array of fixtures and test methods to ensure that tablets behave the way they need to in a physical sense.  These tests ensure that tablets will maintain their integrity from point of manufacture to time of consumption by the customer.  Hardness tests, shear tests, and dissolution tests are becoming the stable of QC Departments to ensure that performance goals are achieved.  Some of the test methods are reviewed in this article. By Bob McGregor, General Manager, Brookfield Engineering

60. Accelerated Tox Offerings: A Recipe For Streamlining IND Applications 4/22/2025

    Accelerating the timeline to tox material can significantly enhance the drug development process, enabling faster IND submissions and providing crucial time savings for toxicology studies.