How a Sample Inventory Management System Supports Scaling from Phase I to Commercialization
In the world of cell and gene therapy, growth is both the goal and the challenge. Early-stage biotech companies begin with a handful of samples, managed in spreadsheets and tracked manually. But what happens when your promising therapy enters Phase II, scales to multi-site trials, and eventually moves toward commercialization? The complexity of managing biological and cell therapy samples grows exponentially, and manual processes simply can’t keep up. This is where a scalable sample inventory system, implemented step by step becomes essential for managing biological and cell therapy samples. In this use case deep dive, we explore how the right …
10 Must-Follow Regulatory Compliance Checks for Storing Biological and Cell Therapy Samples in 2025
In the rapidly evolving landscape of cell and gene therapies, maintaining regulatory compliance for biological sample storage isn’t just good practice, it’s essential for patient safety, product integrity, and business continuity. As regulatory frameworks continue to evolve in response to technological advancements and emerging therapies, organizations must stay vigilant about compliance requirements and how to implement a validated storage system. The stakes couldn’t be higher. A single compliance failure can result in compromised patient safety, regulatory actions, financial penalties, and irreparable damage to reputation. For cell therapy CDMOs, biobanks, and other patient-centric organizations, understanding and implementing these critical compliance checks …
