Although biotechnology pharmaceutical manufacturers have historically placed a strong emphasis on the manufacturing process as a major contributor to product quality, extensive utilization of process analytical technology (PAT) for quality assurance has yet to be fully realized. One impediment is the inherent complexity of protein-based products that makes it difficult to ascertain the product characteristics that are critical to safety, efficacy, and stability. In spite of this, there are many aspects of biotech manufacturing that are amenable to a PAT system of analysis, monitoring, and control which can result in improved productivity, manufacturing consistency, and product quality. This presentation will focus on how manufacturers can begin implementing PAT into their process and what the FDA is doing to encourage this.