Cell and Gene Regulatory

  1. Cell Culture Process Scale-Up Challenges For Commercial-Scale PSC Manufacturing 3/5/2025

    Allogeneic cell therapies offer incredible promise, but scaling up PSC manufacturing presents unique challenges. Explore these hurdles along with solutions for consistent, high-quality production.

  2. Meeting Annex 1: A Proactive Approach To Regulatory Compliance 3/4/2025

    It was imperative for a large European CMO that produces multiple biologic drugs to select the right product quality and value for each customer to comply with the August 2023 revision to the EU GMP Annex 1.

  3. Achieving EU GMP Annex 1 Compliance For Contamination Control 3/4/2025

    Gain insight into three areas that have been key in ensuring a robust contamination control strategy to help ensure compliance with the updated Annex 1 regulation: planning, people, and products.

  4. The Patent Cliff Looms – Design Your Biosimilar Approach Accordingly 3/3/2025

    In your pursuit of developing a high-quality biosimilar, think strategically. Consider what type of biologic your team’s expertise can support and which is needed most in your target market.

  5. Cell & Gene Therapies: Will 2025 Represent A Continuation Of FDA's 2024 Developments? 2/28/2025

    This article recaps the significant FDA regulatory considerations for cell and gene therapies in 2024. Will 2025 see a continuation of these efforts?

  6. What FDA Draft Guidance Tells Us About In-Process Control Strategies 2/28/2025

    The draft aims to modernize the regulations in 21 CFR 211.110 catching up to progress in the field including advanced manufacturing and analytical technologies.

  7. Deciphering FDA's 7-Step Framework For AI-Driven Decision-Making 2/27/2025

    The draft framework, published in January, aims to ensure that AI systems used in drug development are robust, reliable, and aligned with regulatory expectations.

  8. The Ex-Regulator's View On Small Surface Contamination Control 2/26/2025

    Effective small surface disinfection in cleanrooms requires adherence to detailed procedures and best practices. ​Learn about the critical steps, techniques, and validation needed to ensure product safety.

  9. Navigating The Future Of Clinical Trials: Expert Insights For 2025 2/26/2025

    The biopharmaceutical industry is undergoing transformative changes to develop more dynamic and efficient frameworks that prioritize patient outcomes in 2025.

  10. Strengthening Shop-Floor QA From The Ground Up 2/24/2025

    Quality is created where and when manufacturing happens, not later through inspection. This approach integrates the QA function into daily production operations.