Industry Insights

  1. Debunking Myths And Misconceptions About Softgels

    Here, we take a look at some common myths about softgels and explore why drug developers may want to reconsider their go-to delivery methods.

  2. Lessons Learned From A CMC Risk Management Mishap 6/4/2020

    How can pharma and biotech companies establish controls to minimize deviations? What are the critical considerations that should be addressed early on — before issues develop? The short answer: a thorough risk assessment with a focus on CMC. An illustrative example of a company that failed to heed this admonition follows.

  3. 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.

  4. Raw Material Variability: The Need For Deeper Process Understanding 3/2/2020

    Principles and methods for biopharma development and manufacturing are well established, but increased molecular diversity and a drive for higher productivity bring new challenges to process developers.

  5. Fit-For-Purpose Lipids Can Accelerate, Scale, And Improve RNA-LNP Drugs 6/22/2023

    Emerging biotech companies are investing in novel delivery capabilities to address different modalities' needs and extra-hepatic delivery. Explore steps to accelerate commercial nanomedicine delivery.

  6. The Importance Of Feasibility Assessments In The Standards Development Process 7/1/2021

    Accelerating the adoption of standards relating to best practices in scientific protocols, product testing, product quality and performance specifications will help accelerate innovation, encourage precompetitive collaboration, knowledge sharing, and help facilitate the regulatory review process.

  7. Pandemic Prompts Supply Chain Exodus From China — What's Best For Your Business? 4/27/2020

    Decisions made in panic rarely work out for the best. In lieu of abandoning operations in China completely, consider these alternatives to secure your company’s supply chain.

  8. Patent Strategy And The Internet Of Medical Things 5/15/2019

    Not only must new IoMT patents make it through the typical granting process, the market’s size suggests that post-grant challenges may become increasingly common.

  9. Struggling With GxP Systems? There's A DAP For That 4/2/2025

    A typical life sciences enterprise now has 500+ software applications. A digital adoption platform (DAP) is an overlay to help with user adoption, like an advanced version of the MS Word "paperclip" assistant.

  10. Training And Memory Decay In Simulated-Use Testing 10/8/2018

    One topic that often generates confusion — and sometimes heated debate — is whether study participants should be trained on a product’s use prior to testing. Trained participants may be more likely to use the product as intended during testing but, as testing is intended to simulate real-life product use, training may not always be appropriate.