Cell and Gene Regulatory

  1. The Role Of CROs In Drug Development 4/4/2025

    In the rapidly evolving landscape of drug development, Contract Research Organizations (CROs) play a pivotal role. Learn more about CRO and selecting the right one to partner with.

  2. The Early Phase Australian Advantage For Biotech Companies 4/4/2025

    Australia's clinical landscape presents a compelling environment for early-phase clinical trials, characterized by regulatory efficiency and cost-effectiveness.

  3. Development Strategies For Platform Devices Navigating Regulatory Complexities 4/3/2025

    Explore regulatory strategies for platform drug-device products, including bridging formulations, leveraging existing data, and aligning with FDA expectations to accelerate market access and reduce risk.

  4. Timely Lab Data To Inform Outreach To Healthcare Professionals 4/3/2025

    Learn how you can leverage a system that offers flexible data delivery formats and seamless integration into commercialization workflows while also ensuring HIPAA-compliant deidentified data for patient privacy.

  5. Revolutionizing Treatment: How Nanoparticle Platforms Are Unlocking the Potential of Genetic Medicine 4/1/2025

    Explore how the HIT SCAN platform accelerates gene therapy delivery by screening polymeric nanoparticles, enhancing precision, efficiency, and regulatory pathways for next-generation genetic medicines.

  6. Measuring And Monitoring Environmental Surface Residues 4/1/2025

    Explore techniques like visual inspection and TOC sampling to assess surface residues as well as discover the benefits and challenges of these practical methods to achieve effective residue validation.

  7. Characteristics Of Environmental Residues And Protocols For Removal 4/1/2025

    Examine disinfectant residue characteristics, impacts, and removal challenges in cleanrooms, as well as learn about the practical requirements for maintaining cleanliness standards and addressing these residues effectively.

  8. Amgen's Deep Learning Approach To Vial Inspection 3/31/2025

    The company is testing how artificial intelligence can help bring down the number of false rejections caused by factors like glare on the glass or bubbles in the vial.

  9. Indian Biosimilar Companies Are Poised To Succeed In The Global Market 3/31/2025

    For Indian biosimilar developers looking to capitalize on the upcoming patent cliff, it is vital to play to your strengths and identify strategies for breaking into competitive regulatory markets.

  10. 2025 Cell Therapy Outlook From BPI West 3/31/2025

    Bioprocess Online and Cell & Gene spoke with Takeda’s Amy Shaw at BPI West to discuss the industry and her key takeaways from the conference.