Industry Insights

  1. Translating Study Reports – A GLP Draft Guidance 5/6/2024

    The FDA has provided guidelines for the translation of studies conducted by non-US testing facilities, including an expectation that the translated report include a statement of certification requirements.

  2. Solving Drug Shortages With AI 12/20/2023

    Here, we explore the positive impact of artificial intelligence on drug manufacturing and acknowledge some of the key concerns associated with its implementation.

  3. Advancements In Ophthalmic Drug Manufacturing: Precision And Scale

    Learn how a CDMO partner that leverages a multidisciplinary team approach can help you achieve effective scale-up production, handle potent compounds, and ensure regulatory compliance.

  4. CDMO Partnerships In Early Development Aren't Always The Best Choice 12/7/2022

    This article looks at the needs and challenges biotech organizations face during the manufacture of therapies, how they can reduce cost, and how establishing — or not establishing — partnerships with CDMOs can help get their therapies to patients faster.

  5. Regulatory Brief: USP 382 Updates 3/17/2026

    As regulations continue to shift, staying current with the latest expectations is essential for maintaining compliance and ensuring patient safety.

  6. Industry Leading Hybridoma Technique For Accelerated Antibody Discovery 3/27/2025

    Leverage the power of hybridoma technology for efficient monoclonal antibody development, ensuring native gene pairing, class switch recombination, and seamless scalability.

  7. The 3 Stages Of MES Analytics For Drug Manufacturing 6/14/2023

    In order to access all of your organizations manufacturing data and insights, the most practical solution is a cost effective, modern MES for all lines and stages.

  8. The Future Of Pharma Packaging Trends, Technologies, And Patient-Centric Solutions 4/14/2026

    Pharmaceutical packaging must evolve alongside drug development to ensure stability, safety, and regulatory adherence, utilizing innovative designs to improve therapeutic outcomes and patient accessibility.

  9. Understanding FDA's Draft Guidance: Composition Statements Of Ingredients In Labeling In NDAs And ANDAs 6/20/2025

    The FDA's 2024 draft guidance details presentation of a drug product’s composition and the corresponding details of the ingredients in the product labels for NDAs and ANDAs.

  10. New FDA Draft Guidance Provides Insights On Use Of Pros In Oncology Trials 7/26/2021

    Incorporating patient-reported outcomes (PROs) into clinical trials can help sponsors better understand patients’ symptoms and how a therapy will affect their quality of life. Read how that’s changed with the recent publication of a new draft guidance from the U.S Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE), Core Patient-Reported Outcomes in Cancer Clinical Trials.