Industry Insights

51. A Road Map For Transitioning From A Research-Focused To Commercialization Mindset 6/3/2025

    As the timeline for commercialization closes in, it’s necessary to best position the organization for a successful launch. Where to start?

52. How to Ensure Your Quality Culture Assures Data Integrity 4/14/2021

    One solution to ensuring data integrity is to automate the process, essentially removing the human element. But not all instances of data generation/capture can or should be automated. With humans – our team members – engaged in data generation/capture, the quality culture is a major pathway to assuring our data have integrity.

53. Autonomous Supply Chain Planning Is Within Reach 10/19/2022

    In a fast-paced industry constantly innovating — from personalized medicine to health wearables — life sciences companies must be prepared to adopt transformative technologies that can help them meet the demands of the future of medicine. Autonomous supply chain planning is not science fiction; it's here, and it's now. Building a practical road map will help.

54. Private Equity Accelerating Consolidation In The CDMO Market 7/16/2019

    The CDMO industry has benefitted from big pharma’s divestment of in-house development and manufacturing capabilities in this current economic cycle. The sector has grown at a consistent 7 percent compound annual growth rate (CAGR) for the better part of a decade, outpacing that of the greater pharmaceutical industry itself. The rise of competition from new CDMO players and consolidation within the pharmaceutical sponsor space, however, has led to a crowded market and, in many cases, a commoditized service base.

55. Rethinking Manufacturing Processes To Identify Green Opportunities

    Reducing the carbon footprint of your pharmaceutical fine chemicals manufacturing process requires a shift from the traditional process development approach. Sustainability requires revolutionary changes.

56. FDA Proposes Updated Guidance On Verification Systems Under DSCSA 4/19/2022

    The FDA is soliciting comments on its proposed update to its "Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs" guidance. When a trading partner suspects counterfeit or fraudulent products, or receives a request for verification from the FDA, partners are required to quarantine the product and to investigate its legitimacy. 

57. Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 2 10/27/2023

    This article, part 2 of a 3-part series, examines the prerequisites phase, development and approval of the study protocol phase, execution sequence, and post-execution of a continuous gage repeatability and reproducibility (R&R) study for drug delivery system measurement system analysis.

58. Fermentation Of Live Biotherapeutic Products In cGMP Environments 10/8/2025

    We follow the journey from master cell bank to large-scale anaerobic fermentation, highlighting the unique needs for working with oxygen-sensitive, strictly anaerobic therapeutic microbes in a cGMP setting. 

59. Managing Contamination Risks In The Pharmaceutical And Medical Device Industries Using Relational Risk Analysis 2/18/2025

    Of all the risks associated with pharmaceuticals and medical devices, controlling contamination is one of the most important and difficult challenges. Relational risk analysis (ReRA) can help.

60. Can CHO Bioreactors Be Used For Plant-Based Protein Production? 9/22/2025

    The moss Physcomitrium patens is especially good at producing glycoproteins. Established technology and prior knowledge are helping one company develop new therapies with it.