Industry Insights

  1. Why You Need A Raw Material Control Strategy 4/17/2025

    You should start with the end goal in mind, but the first draft is almost never the last. These living documents should evolve as your team gains process knowledge.

  2. Why Pharma Risk Assessments Should Include 'Working Together Alone' 4/16/2025

    When understood and managed properly, subjectivity becomes a source of creativity. It reveals hidden hazards and unlocks more effective risk controls.

  3. How CAR-NKs Offer Powerful Therapeutic Flexibility 4/15/2025

    Induced pluripotent stem cells have emerged as a promising platform for producing CAR-engineered NK cells in a standardized, renewable, and scalable way.

  4. Ramping Up GMP-Compliant CAR-NK Manufacturing At Scale With iPSCs 4/15/2025

    The ability to produce billions of NK cells in a single production run represents a transformative shift in the economics and logistics of cell therapy.

  5. Pharmaceutical Sovereignty: The Resilience We Cannot Outsource 4/15/2025

    Pharmaceutical sovereignty is no longer a theoretical concern. Sovereignty in this context does not imply isolation, but rather strategic resilience: building robust national and regional capabilities that ensure security while enabling global collaboration. 

  6. From Tissue Donation To Distribution: Understanding EU Regulatory Requirements In Cell Therapy Clinical Trials 4/14/2025

    Understanding how the European Union's Directive 2004/23/EC interacts with GMP — and where its jurisdiction begins and ends — is essential for successful clinical trial planning, compliance, and execution.

  7. The Cell and Gene Therapy Dilemma: Centralized Vs. Decentralized Manufacturing 4/11/2025

    This article explores key factors to consider when determining whether a centralized or decentralized model is best suited to support access for a specific CGT product, depending on the condition and context.

  8. How Cynata Therapeutics is Unlocking the Power of iPSCs to Transform Regenerative Medicine 4/11/2025

    Cynata Therapeutics is pioneering a scalable, iPSC-based platform to produce consistent, high-quality MSCs that are showing strong clinical promise across multiple indications, including GvHD, diabetic foot ulcers, and osteoarthritis.

  9. Smart Trial Design In Cell Therapy: Fast-Tracking Without Compromising 4/10/2025

    Discover clinical trial designs and real-life examples that enable fast and safe studies in cell therapy.

  10. How AI Is A Game-Changer For Auditing Compliance And Efficiency 4/9/2025

    In the life sciences, audits have long been bogged down by repetitive tasks. AI is changing the way auditors operate, making compliance more seamless than ever.