Industry Insights

  1. Design, Operation, And Automation In Aseptic Filling Systems 6/17/2024

    Learn about a modular and compact filling and closing system for flexibility in pharmaceutical manufacturing operations and automated processing of vials, syringes, and cartridges.

  2. Mass Spectrometry For Drug-Protein Interaction 5/13/2025

    Discover how mass spectrometry can transform your drug discovery efforts by delivering precise, reliable quantification of drug-protein interactions for optimized assay development and dosing strategies.

  3. Why Life Sciences Needs The Science Of Security 1/6/2021

    Given the complexities that arise when securing data in drug development and developing software that facilitates common workflows, ensuring best-of-breed security simultaneously is the key to success.

  4. Balancing Speed-to-Market With A Risk-based Approach To Compliance 10/1/2015

    Addressing compliance pressures can drastically affect productivity and manufacturing cycles, so a risk-based approach to compliance can help biopharmaceutical companies balance the scales. When not everyone in the industry can be “first-to-market,” it’s important to glean information from being the “first-to-fail.”

  5. Relational Risk Analysis For The Bio/Pharma Industry 1/29/2024

    Successfully developing and manufacturing biopharmaceuticals depends on identifying, analyzing, and managing a wide variety of risks. This article presents a novel alternative risk analysis approach that provides a simple, easy, and effective method for quickly and efficiently modeling and analyzing any risk.

  6. 3 Focus Areas To Transition From Clinical To Commercial Readiness 11/12/2024

    Transitioning from clinical-stage operations to commercial readiness is a multifaceted process. Establish compliant and robust distribution systems by focusing on these three areas.

  7. Effective Staffing Plans For GMP Drug Manufacturing Facilities 8/12/2024

    In the manufacturing industry, the proper planning and staffing of GMP facilities and production lines are crucial for efficient operations and successful outcomes.

  8. Stages 2 And 3 QbD Validation Strategies For Nonsterile Solid Dosage Forms 4/11/2013

    In my previous communication in February, I provided an overview of stage 1 QbD validation strategies for process design for nonsterile solid dosage forms. In this article, I will continue to highlight strategies for validation prior to release of a commercial product (stages 2 and 3).

  9. FDA Seeks Comment On ICH Q9(R1) Quality Risk Management 7/5/2022

    ICH has revised Q9 Quality Risk Management, providing principles and tools that can be applied throughout the product life cycle of drug substances, drug products, biological, and biotech products. The FDA, a founding member of the ICH, plays a major role in the development of ICH guidelines, which FDA then adopts and issues as guidance to industry. 

  10. How To Achieve Right-First-Time Manufacturing 1/21/2026

    Modernizing QC requires more than isolated fixes. Discover how cloud-based platforms unify systems, automate workflows, and improve data access to help labs reduce cycle times and minimize rework.