PAT is defined as a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality. The Food and Drug Administration has put forth the PAT initiative to accelerate pharmaceutical industry’s adoption of innovative approaches towards product quality. A desired goal of the PAT initiative is to build quality into processes in order to consistently ensure a predefined quality at the end of the manufacturing process.
Biokinetics possesses a multi-disciplined staff of engineers with expertise in the realm of PAT. By utilizing the concepts of PAT, Biokinetics, acting as manager/facilitator or as part of our clients’ internally organized team engineers can work with drug manufacturers to gain a thorough understanding of their process, and therefore consistently ensure a predefined quality at the end of the manufacturing process. PAT service offerings include: PAT master planning, application of process sensors and controls, statistical analysis, risk analysis, and continuous improvement/knowledge management. Some of the benefits of implementing a PAT program include: reducing production cycle time, process variability, rejects, and reprocessing; real-time release; improved efficiency, safety, and energy and material use.
Biokinetics is a recognized industry leader in process systems design for the bio/pharmaceutical industry, with expertise in bioprocess unit operations including fermentation, mammalian cell culture, bioreactors, bacterial and yeast fermentation/recovery, live and attenuated virus processes for vaccines, and plasma-derived products; associated processing and support systems; pharmaceutical fill-finish and materials handling; process simulation and optimization; modular process design; high-purity water systems; and validation services.
For more information contact:
Todd Rumsey, Biokinetics, Inc. 215-656-2998
