Cryopreservation for Critical Starting Material Products: Benefits of Effective Cold Chain Management
Advanced cell-based therapies, such as chimeric antigen receptor (CAR)-T cell therapies, are changing the landscape of healthcare, expanding treatment options for patients beyond previous standards of care in major disease areas. To ensure successful cell therapy outcomes, the timely and reliable delivery of high-quality cellular materials to drug developers with active clinical trials and, ultimately, […]
Case Study: OrganaBio’s Hub Processing Model
INTRODUCTION This case study examines how OrganaBio’s unique Hub Processing Model successfully addressed the critical needs of two multinational pharmaceutical companies conducting mRNA vaccine trials for COVID-19, influenza, and RSV. The Sponsors required a cell processing partner with expertise in: Maintaining stringent quality and process controls: OrganaBio achieved a near-flawless 99.9% processing success rate across […]
Getting Off to a Good Start
Why finding high-quality donor cells is so important in cell therapy development? Key Challenges: Variability in donors: Human cells naturally vary, creating challenges in standardizing therapies and ensuring quality. Limited donor pool: Finding compatible donors is difficult, and strict requirements further shrink the pool. Donor sustainability: Recalling the same donors for repeated donations and ensuring […]