INSIGHTS ON CELL & GENE REGULATORY ISSUES

• 100% U.S. Drug Tariffs: Implications For Pharma And Outsourcing

  Research Manager Mathini Ilancheran explores the effects of U.S. drug tariffs on global supply chains, multinational pharma firms, and critical partners across drug development.

• IVD And CDx: Comprehensive Services From Research To Regulatory

  Navigating diagnostic development requires deep scientific expertise and adept regulatory support. Comprehensive solutions offer biospecimens, biomarker development, clinical trial support, and global regulatory services.

• Top 5 Challenges In Psoriasis Trials (And How To Overcome Them)

  Psoriasis trials face recruitment, endpoint, regulatory, and operational challenges. Identifying common hurdles early helps sponsors streamline processes, avoid setbacks, and prevent costly delays.

• What Can The Tech Sector's 'Minimally Viable' Concept Teach Biopharma?

  Deciding what is good enough to get started can support the mindset of building something without sacrificing quality, functionality, or safety.

• How AI and ML Drive iPSC Quality with Aspen Neuroscience's Thorsten Gorba, Ph.D.

  In Episode 113 of Cell & Gene: The Podcast, Host Erin Harris is joined by Thorsten Gorba, Ph.D., of Aspen Neuroscience to explore how the company is advancing the field of cell therapy manufacturing.

• Engineering Bacterial Vector-Based Immunotherapies With OS Therapies' Paul Romness and Robert Petit, Ph.D.

  In this episode of “Better Biopharma,” host Tyler Menichiello is joined by OS Therapies’ CEO, Paul Romness, and chief medical and scientific officer, Robert Petit, Ph.D. The three discuss the development and manufacturing of the company’s lead asset, OST-HER2, a Listeria-based immunotherapy for osteosarcoma.

• How Strategic CMC Planning Drives Cell Therapy Success

  CMC is essential for cell therapy success, with FDA CRLs often due to CMC gaps; early strategic planning and robust controls reduce risks and accelerate market approvals.

• Regulatory Bar Raised For Cell Therapies: Are You Ready?

  Since 2024, multiple cell and gene therapy programs faced regulatory delays due to manufacturing deficiencies, highlighting the critical need for robust CMC strategies and inspection-ready operations.

• The Shift To GMP-Compliant Automation In CGT Manufacturing

  Manual processes are yielding to automated, GMP-compliant closed systems in CGT manufacturing. This shift is crucial for meeting Annex 1 contamination standards and creating scalable, reliable commercial production.

• What Does Annex 1 Mean For Cryovial Filling?

  New sterile manufacturing rules require major changes to cryovial filling. Ensure compliance by adopting better "first-air" protection, minimizing human contact, and using 100% dose checks.