Industry Insights

31. Leveraging Advanced Analytical Capabilities To De-Risk Drug Development

    Characterizing a molecule's identity enables efficient process development and regulatory compliance. To achieve this, sponsors must leverage advanced analytical techniques that illuminate structure and purity.

32. Quality Metrics: How To Add Value And Meet The FDA's Expectations

    Establishing and utilizing quality metrics is essential for the pharma industry's future success. Learn how to identify meaningful metrics and appropriately measure quality to make better business decisions.

33. Selecting The Best Human Factors Method For Your Medical Or Drug Delivery Device Evaluation 7/21/2021

    A robust human factors process is critical to product optimization and market competitiveness for medical devices and drug delivery devices, but not all companies have the resources, funding, or time to conduct such user studies. Genentech's head of human factors engineering examines the three major categories of evaluation that you should consider, the pros and cons of each, and how to select study participants.

34. The Power Of AI To Improve Clinical Trial Monitoring 4/11/2025

    By analyzing patient data sets, AI enhances predictive analytics, supports real-time patient alerts, and strengthens continuous monitoring — improving the effectiveness of clinical trial oversight.

35. A CMO's Roadmap To Net Zero: Adding Value Through Sustainable Practices 12/26/2023

    Learn how CMOs are navigating the path to net zero by utilizing planet-conscious talent and partners and review key considerations for reducing emissions throughout development and manufacturing.

36. Viruses And Viral Vectors, Are They Different? 10/23/2024

    Learn how effective disinfection solutions can ensure safety in pharmaceutical manufacturing by managing viral contaminants and enhancing patient protection.

37. Integration Of Quality Management And Manufacturing Automation Systems 9/29/2023

    Quality by design (QbD) is enormously valuable but often underutilized, siloed, and not operationalized. Discover the benefits of enabling QbD with AI-driven quality operations and batch automation.

38. Updating Palletization To Increase Product Safety 4/25/2012

    Some pharmaceutical companies have already moved to streamline and upgrade their supply and manufacturing chains. By Rex Lowe, President, iGPS

39. All Eyes On X-Ray Inspection For Big Box Retailers 12/16/2024

    Major retailers are mandating x-ray inspection for their suppliers. Uncover why this technology is crucial, and its capabilities beyond contamination detection to encompass vital quality and integrity checks.

40. Revising Annex 1: A Case Study In Controlling Operating Risks By Understanding Uncertainty 11/13/2020

    Unfortunately, the pharmaceutical industry does not understand how to control a risk’s likelihood of occurrence. The current draft of EU GMP Annex 1 is an example of the industry’s focus on a risk’s severity while not understanding or evaluating a risk’s uncertainty and thus defaulting to using the precautionary principle for guidance.