Industry Insights

81. Embracing An Economic Model For Agile Process Development 11/27/2024

    If AI-led discovery brings the surge in new candidates it promises, will process teams be ready?

82. Nitrosamines: New WHO Guidance Provides Expanded Risk Assessment Considerations 5/6/2024

    Nitrosamines are potential contaminants of drug products. Contamination can occur from synthesizing APIs and excipients, from leaching into the product from primary packaging, and more.

83. Polymeric Materials in Bioresorbables and Point of Care Medical Devices 9/22/2021

    The latest generation of polymers, as well as forward-looking generations of polymer composites in medical devices, discussed in this article include bioresorbable polymers (from drug delivery to surgical implants), wearable point of care testing devices, inherently conducting polymers and composites, thermal conductive polymer composites, and calcium phosphate-based composites.

84. The Digital Health Tsunami Is Here. How Is FDA Gearing Up? 4/19/2018

    The FDA’s Software Precertification Pilot Program moves away from the agency’s long-held stance that it does not “approve companies,” exploring new thinking on how to regulate by reputation and continuous improvement loops, rather than reviewing each and every low-risk product. Might there be a way to replicate this type of thinking for complex products?

85. Solving Atypical Protein Expression With Transposases 1/21/2026

    To optimize productivity and avoid costly delays for complex proteins, researchers should leverage flexible platforms and experienced CDMOs in cell line development.

86. Data Management: 5 Best Practices For Emerging Biotechs 2/14/2022

    Whether your ambitious upcoming pharma startup or biotech has its sights set on being the world’s first in your field, or a lucrative exit through a strategic company sale, starting out with good data management practices will set you up for success for the future you envision.

87. Extension Of The Patient: Expanding The Role Of Caregivers In Biopharma Development 2/18/2020

    For medical product developers, the role of the caregiver is increasing as innovation advances. Caregivers may provide input on clinical trial concepts, protocol design, informed consent creation, and may also improve clinical trial recruitment and retention.

88. FDA Updates Guidance For Investigating OOS Test Results 6/24/2022

    FDA's CDER has released a guidance sharing the agency's recommendations on how to evaluate out-of-specification (OOS) test results, including the responsibilities of lab personnel, the lab phase of the investigation, additional testing that may be necessary, when to expand the investigation outside the lab, and the final evaluation of all test results.

89. Starting Smart: Building Early CGT Supply Chains 6/26/2025

    Discover how building a scalable, compliant supply chain can set your CGT program up for long-term success and avoid risks that could derail progress down the line.

90. Digital Certificates Of Analysis: A Vision For The Transfer Of Quality Data 1/23/2025

    The pharma/biotech industry must ramp up adoption of digital certificates of analysis, which are transforming the way quality data is transferred between organizations in the supply chain.