Robust Cell Therapy Manufacturing

Cell therapy is a promising alternative to traditional disease treatments, but its complexity and strict manufacturing guidelines limit its availability. Challenges include variability in starting materials, adherence to Current Good Manufacturing Practices (cGMP), and transitioning from manual to adaptive process strategies. Critical process parameters such as amino acids, glucose, lactate, and cell density need careful monitoring and control. Selecting, developing, and optimizing media for cell therapy using primary and stem cells pose additional challenges.