Process Development is an important component of manufacturing. BioMARC believes that developed processes should be supported by improved understanding of the processes. Good design of experiments and evaluation of results will allow for more efficient and high quality decision making.
Upstream (Bulk Processing) and Downstream (Drug Materials) development studies are designed evaluate the process for intended use. Development is carried out in such a way that the type and scope of the data generated will allow for sufficient evidence of the reproducibility of the process. Development of the process will focus on designing studies and generating data based on critical criteria outlined in the Project Specific Project Plan. Each process control is based on an interpretation of a base of representative data. Processes in which the interaction between critical process parameters and the variable properties of the starting material is not known will be reproduced rigidly to obtain significant data. Process development includes analysis of independent process steps and well as the entire production process within a pilot and/or engineering batches. All developmental activities are documented and reported in support of the product’s life cycle.
BioMARC can work with your goals and build a pathway for the development of your upstream and downstream bioprocessing activities. Contact us to learn more!