Industry Insights

  1. New 'WEE' Urgency Raised As FDA Requires DSCSA EDDS Interoperability 6/28/2024

    A June meeting showed industry is struggling to meet the DSCSA's November deadline. Eligible companies might find relief in an FDA waivers and exemptions program.

  2. Defining Holistic Asset Criticality To Manage Risk In Biopharma

    This article presents how risks to safety, quality and productivity can be managed through asset control strategies, which are created based on specific asset criticality and failure modes.

  3. Imagine The Future: Enhanced Oligonucleotide Synthesis 3/4/2024

    Learn about flexible control software that has revolutionized the way method creation, evaluation, and process optimizations for scale-up are completed.

  4. Safeguard HPLC Data Quality With Planned Performance Maintenance 4/12/2022

    Learn how to safeguard your data quality by ensuring your HPLC instrument remains consistently in peak condition.

  5. Approaches To Improve Efficiency In Biopharmaceutical Process Development 5/5/2020

    Time to experiment, time to clinic, and time to market are becoming even more important for developers and manufacturers of biopharmaceuticals. These tools make process development more efficient.

  6. 10 Critical Validation Parameters For Microbiological Experiments 7/26/2021

    In studying a microbiological method, different validation parameters require assessment. These are variables or factors that can be controlled, changed, or measured in the experiment. This article outlines the key parameters to consider.

  7. The Rise Of Complex OSD Generics: Understanding Development Challenges 12/11/2024

    Understanding the potential pitfalls and partnering with the right experts can make all the difference in overcoming the complexities of complex generic OSD development.

  8. Drug Labeling: 3 Pitfalls To Avoid And 8 Best Practices To Follow 12/7/2023

    You may have processes in place to prevent drug labeling errors, but they can still occur. Here are three common pitfalls and the eight best practices you should be employing to make sure they don't happen.

  9. Development And Manufacturing: Success With HPAPI

    Dr. Michiya Hayakawa shares strategies for manufacturing HPAPI (highly potent active pharmaceutical ingredient) drugs and key points for promoting projects that utilize special formulation technologies.

  10. Outsourcing issues: the multi-product challenge 10/9/2000
    Forecasts show some 300 new FDA drug approvals during the next decade, based on the unprecedented flow of about 3000 new compounds into the pipeline...