ABSTRACT

The biotechnology operation focuses on development of a speci­c product. This concept carries with it the need to plan and then develop a biomanufacturing process to produce a biological substance of high quality and in amounts required for testing and marketing. Further, the biomanufacturing processes and the resulting product must be compliant, that is, they must satisfy regulatory agencies through application of good science and a quality system: current Good Manufacturing Practices (cGMPs). To achieve these objectives, the biotechnology operation must develop a biomanufacturing plan.