Knowledge Center
Dive into a curated collection of insights and expert articles designed to keep you informed on the latest trends, innovations, and developments in advanced cell therapies. Our Knowledge Center is your go-to resource for reliable, science-driven information to support your work and inspire new ideas.
Navigating Assay Validation in Cell Therapy
Bringing cell therapies from the laboratory to patients isn’t just about innovation—it’s about trust. Every step of the journey, from early research to full-scale production, depends on the ability to measure, analyze, and understand these living therapies with confidence. At the core of this trust lies assay validation, the process that ensures each analytical method is precise, reliable, and aligned with the highest quality and regulatory expectations.
ASC Challenges: Expert Insights from Louis Casteilla
Adipose-derived stem cells (ASCs), a specialized subset of mesenchymal stem cells (MSCs), offer significant potential in regenerative medicine. These easily accessible cells, derived from adipose tissue, share many of the regenerative and immunomodulatory properties of MSCs, making them highly valuable for innovative therapeutic applications. Louis Casteilla, a leading expert on ASCs, provides a scientific perspective on their potential to advance modern medicine.
How to ensure a seamless IMPD/IND approval
The submission process for IMPD and IND applications in the field of cell therapies presents numerous challenges. Developers must navigate strict regulatory requirements, evolving guidelines, and complex manufacturing considerations to demonstrate product consistency and safety. This article explores the critical elements of regulatory compliance, offering practical insights into how to approach early interactions with agencies and structure high-quality documentation.
The importance of the QTPP for Cell Therapy Developers
The Quality Target Product Profile (QTPP) serves as a strategic guide for aligning the development of cell therapies with clinical objectives and regulatory standards. Establishing a clear QTPP early helps teams anticipate risks, structure their development plans, and define the critical quality attributes (CQAs) essential for product performance. This recommendation notice outlines practical guidance for building an effective QTPP, including considerations specific to cell-based therapeutics.