Process Development Associates evaluate biomanufacturing processes, improve them, and scale them up for larger batches of materials. Their goals are to improve product yield and reduce overall costs of production. In addition to scaling up to produce larger amounts, these associates also work on small batches of materials. An analogy can be made to baking cookies. A small batch would be a dozen cookies. A scaled up batch could be cookies for the whole state of Wisconsin.
Process development associates produce products using cell culture or fermentation and employ diverse techniques to purify these products. They help test for purity and develop assays for purified samples. They troubleshoot and help resolve the problems associated with different phases of full-scale biomanufacturing production. They work on packaging sterile materials in a contamination-free environment (aseptic fill process) and assist in maintaining equipment used for production. Other packaging and distribution procedures also fall within their responsibilities. Process Development Associates contribute in researching, developing, and implementing new methods and technologies to improve production.