Industry Insights

  1. Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms 9/16/2025

    Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad events. 

  2. Polymeric Materials And Coronary Angioplasty Devices 4/14/2021

    Polymer physics and mechanical engineering principles contribute significantly to the advancement of percutaneous transluminal coronary angioplasty (PTCA) and balloon catheter expansion. This article discusses controlled drug release from various components and forward-looking applications such as electronic-enabled catheters and stents as well as bioresorbable and 3D printed stents.

  3. The Evolution Of Biomarker-driven Approaches To Clinical Trials 12/1/2020

    Greater understanding of the specific and varying genetic bases for cancers has provided greater opportunities for clinical trials to take advantage of patient genetic variability for recruitment and segmentation purposes. In this article, historic data provide insights into the evolution and future of biomarker use in precision medicine.

  4. The Global Market Landscape For Peptide Drug Conjugates 3/17/2023

    A peptide drug conjugate is a type of drug molecule that combines a peptide with another molecule, such as a small molecule drug or a protein, to create a new compound. New market research shares key factors and trends driving the market, as well as market segment insights.

  5. A Practical Packaging Components Checklist For Emerging Biotechs 6/20/2024

    A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations when selecting components for your injectable drug product.

  6. 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.

  7. A Novel Approach To Managing Risks In Aseptic Processing Of Cell & Gene Therapies 2/21/2024

    Establishing a robust contamination control strategy for advanced therapy medicinal products, also referred to as cellular and gene therapy products, is of utmost importance. We must employ risk assessments and risk-based approaches. In this article, the authors introduce the aseptic risk evaluation model (AREM), which is compliant with the evolving global regulatory landscape and best practices.

  8. Is Excessive Pressure in The Feed Frame Causing You Problems? 6/5/2024

    Are you having content uniformity issues in oral solid dosage manufacturing? Your slide gates and valves might not be in the best position with relationship to the powder feeder.

  9. MDR Delay Is An Opportunity To Excel, Not An Excuse To Relax 5/25/2020

    While the MDR date of application has been delayed a year, the Regulation’s final compliance date has not changed. This article discusses general concerns medical device manufacturers should keep in mind as they adjust to the new timeline, as well as four critical MDR factors to address (or revisit) moving forward.

  10. Stay cGMP Compliant: Instrument Requalification In Pharma 3/10/2026

    Maintaining equipment is an ongoing GxP requirement. Learn what triggers requalification, why it matters for operational continuity, and how proactive evaluation helps prevent costly disruptions.