Process and analytical development in peptide pharmaceutical industries are the key foundations to build an in-depth process understanding allowing to set the best control strategy of peptide manufacturing processes. Throughout the scale-up manufacturing process, the robustness of the control strategy is consolidated and demonstrated in process validation batches. This presentation illustrates the journey to set an efficient, safe and robust commercial manufacturing process through an in-depth investment in the control strategy design and green chemistry application. Successful case studies will be shared.
