Our Expert Network

  1. Unpacking The Importance Of Lipid Nanoparticle Production Platforms 4/15/2024

    Batch processing platforms for LNPs lack efficiency, appropriate controls, and yield optimization. Continuous manufacturing platforms may address some of those issues.

  2. A Promising Approach To Develop An Inhalable, Temperature-Stable COVID-19 Vaccine 4/12/2024

    There are limitations to the currently available COVID-19 vaccines. An inhalable dry powder approach offers promising benefits, such as eliminating cold chain requirements, allowing for more widespread immunity.

  3. AI And Pharmaceutical Development: WHO Calls For Ethical Framework, Good Governance 4/8/2024

    The World Health Organization (WHO) recently released a document titled Benefits and risks of using artificial intelligence for pharmaceutical development and delivery describing the ethical issues and governance considerations for using AI in drug discovery, preclinical development, and clinical trials.

  4. When Does GMP Matter In Non-GMP Settings? 4/5/2024

    Would you ever need to follow GMP standards in workspaces where GMP is not required or possible? This article digs into why, when, and how to follow the principles of GMP.

  5. Fine-tuning Analytical Development Strategies For Every Phase 3/22/2024

    Analytical challenges morph phase-by-phase during drug development. Three Novartis scientists describe a platform approach based on guidance from the ICH and USP.

  6. Navigating Grades And Sources Of Materials In Drug Manufacturing 3/22/2024

    From raw materials to finished dosage forms, understanding material quality is essential in drug manufacturing. This article examines how material grades and sources guide selection for optimal safety and functionality.

  7. A Guide To Proactive Supplier Management In The Pharma/Biotech Industry 3/21/2024

    Proactively mitigate supply disruptions with strategic supplier selection and diversification, effective communication, risk management, quality assurance, and more.

  8. Process Development With “The End In Mind” For Startups 3/20/2024

    We encounter the term “the end in mind” in product development frequently, but many are unsure what it really means and when it matters. This article sheds light.

  9. What Proposed Plasmid DNA Standards Say For GMP/Non-GMP Production 3/8/2024

    Today’s standards for plasmid DNA production lack specificity, and manufacturers have been clamoring for more. In late 2023, USP published draft General Chapter <1040> to help fill in the cracks.

  10. 8 Key Takeaways Of The Proposed FDA Modernization Act 3.0 3/6/2024

    On Feb. 6, 2024, new legislation was introduced in the House of Representatives: the FDA Modernization Act 3.0. It aims to reduce and replace the use of animals in nonclinical research, improve predictivity of nonclinical testing, and potentially reduce drug development times. This article shares an overview. Note that the proposed legislation would still need to go through its course of passing the House and Senate and being signed by the president before becoming a law.