INSIGHTS ON CELL & GENE REGULATORY ISSUES

• ICH Quality Risk Management Guidelines For Biopharma Manufacturing

  The latest revision to the ICH Quality Risk Management guideline aims to optimize efficiency, effectiveness, and scientifically grounded control strategies. Explore the key changes in these guidelines.

• Navigating EU GMP Annex 1 Revisions In Drug Manufacturing

  Explore changes introduced by the revised EU GMP Annex 1, key considerations to maintain compliance, and stark statistics that underscore the consequences of non-compliance in this evolving landscape.

• Cell Culture Supplements To Accelerate Stable Cell Line Development

  Here, we demonstrate the ability of animal component-free Insti CHO and HEK cell culture supplements to enable the industry to overcome cell culture limitations while meeting regulatory requirements.

• Trends In Next-Generation Delivery Technologies

  Learn how lipid nanoparticles are enabling a new generation of engineered cell therapies with a push toward more complex cell engineering and gene editing for allogeneic therapies.

• Design–Build Cleanroom Projects: A Proven Risk Mitigating Methodology

  Learn about the rising demand for cleanrooms in the biopharmaceutical industry, factors driving cleanroom design, building in flexibility, the role of critical path assessments, and more.

• 4 Considerations For Overcoming Challenges In Gene Therapy Testing

  With continuously evolving gene therapy regulations and guidance and limited time during development for testing, here are four points to consider when planning product-release testing of your gene therapy product.

• How Creative Licensing Can Improve Patient Access

  Members of Caring Cross and UC Berkeley's Innovative Genomics Institute and Office of IP And Industry Research Alliances discuss the important role technology transfer offices (TTOs) play in improving ATMP accessibility. TTOs can accomplish this by designing "strings-attached" research and licensing deals upstream in product development.

• The Closed Processing Advantage: Optimizing Biopharma Facilities

  Explore the evolving landscape of biopharma facility design and operations, including key market trends, closed processing benefits, and industry efforts to harmonize guidance and best practices.

• CGT Trials — The Synergy Of CRO And Specialty Logistics Collaboration

  Learn how the right CRO partner is crucial to support the uniquely complex logistical needs of CGTs while prioritizing the working conditions of investigators and the comfort of trial participants.

• Your Local Affiliates Want More From Your Global Regulatory Information Management

  Achieving regulatory excellence depends on a combination of process optimization, effective global systems, high data quality, and better local affiliate collaboration. This article shares key takeaways from new survey results from local offices/affiliates representing 94 countries.