Industry Insights

  1. Planned CDRH Reorganization Will Impact Device Approvals and Inspections 3/14/2018

    The FDA Center for Devices and Radiological Health (CDRH) has proposed a reorganization that will collapse the Center’s seven offices into four, combining siloes of expertise into a new office that aligns talent into teams by product type and technology. Find out how this change may affect you. 

  2. Strategies For Minimizing The Impact Of Bioburden And Sterility Testing On Gene Therapy Batch Yield 1/2/2024

    It is widely recognized that gene therapy manufacturing processes result in low yields. This article outlines strategies for reducing the volumes required for bioburden and sterility testing and, therefore, conserving product for patients while remaining compliant and delivering process information on the microbiological status. 

  3. Targeted Protein Degradation: Challenges And Opportunities 8/1/2022

    Degradation is a significantly different modality from small molecule inhibition, as PROTACs have a catalytic mode of action, event-driven pharmacology, and can target undruggable proteins with shallow pockets.

  4. USP Unpacks The Evolving HCP Identification And Quantitation Story Behind <1132.1> 8/18/2023

    Traditional ELISA methods can fall short of detecting some host cell proteins, so the United States Pharmacopeia has proposed a new general chapter to account for the increased use of mass spectrometry in conjunction with HCP ELISA.

  5. The Digital Future Of CMC Regulatory Affairs 6/23/2023

    This article discusses recent initiatives from the FDA, such as KASA, PQ/CMC, and the ICH SPQS. Let's look at how they could be the early birds of the paradigm shift from electronic CTDs to digital CTDs. The article also addresses what steps the industry should be taking in parallel with the authorities in preparation for this (very near) digital future.

  6. WorldwideEdge™: Driving Innovation In Bioanalytical Lab Run Success Rates 9/17/2024

    Learn more about how the WorldwideEdge™ initiative is driving innovation and efficiency in bioanalytical labs, and how these improvements could benefit your next Phase 1 study.

  7. Innovating During The COVID-19 Pandemic

    Pharmaceutics International, Inc., (Pii) is a premier CDMO, offering unparalleled scientific insight and depth of product knowledge, while supplying high-quality dosage forms that enhance the lives of patients worldwide. Pii provides customized and flexible solutions across several dosage forms and has experience with a broad range of compounds.

  8. wNMR: Spectroscopy From Biomanufacturing to Point-Of-Care 12/29/2021

    Biomolecular NMR spectroscopy work requires highly trained personnel. Sample preparation can be laborious, as biomolecules often require isotopic labeling/enrichment. High-field NMR spectroscopy isn't well suited for manufacturing plants or clinics. Enter wNMR, a noninvasive analytical technology that operates in settings where others are ill suited. 

  9. Further Adapting New Bioprocess Technology In An Era Of Change 5/8/2020

    Biopharma 4.0 is becoming more tangible every day. Catch up on the initiatives and programs that are defining the application of Industry 4.0 principles for MilliporeSigma technologies and services.

  10. 6 Tips For Successful Drug Discovery Teamwork 12/16/2022

    While people don’t always think about the choreography of good scientific teamwork, there are factors that should be considered and skills that can be developed to increase a drug discovery team’s overall effectiveness and chance of success.