PROCESS DEVELOPMENT AND GMP MANUFACTURING
As cell therapies gain traction as a promising new therapeutic modality, emphasis is on robust and reliable scale-up to ensure their clinical and commercial success. Celonic offers expertise and capabilities in cell therapy development and manufacturing – from process development and optimization up to commercialization, including GMP manufacturing for human clinical trials.
Regulatory approval of two patient-derived cell therapies for hematologic malignancies marked the beginning of a new era for cancer and other hard-to-treat diseases. Such transformational cell therapies require a highly controlled production strategy combining single-use technologies with automation, process monitoring and control, to deliver consistent batches with high efficiency.