Continuous Manufacturing for the Pharmaceutical and Biotech Industries
Today, most pharmaceutical and biotech manufacturers utilize batch processes to produce drug products, which are inherently less efficient, more time consuming and costly than continuous ones. The inefficiency is primarily due to the "start-stop-inspect" sequence of operations required during the batch manufacturing process to ensure that the drug product being produced is in full compliance with the quality specifications.
QbD Process Technologies' software products, services and solutions are designed to enable pharmaceutical and biotech manufacturers to consistently produce drug products to pre-defined and measured Critical Quality Attributes in real-time utilizing a continuous manufacturing process. This concept is consistent with the Food and Drug Administration's Quality by Design (QbD) and Process Analytical Technology (PAT) initiatives, which suggest that quality should be "built-in" to control strategies and manufacturing processes. The following table illustrates the differences between current practices and the QbD approach to pharmaceutical development and manufacturing based on guidance recommendations proposed in the FDA's QbD and PAT initiatives.
Quality by Design (QbD)
A Comprehensive Systematic Approach to Pharmaceutical Development and Manufacturing
Table excerpted from a presentation entitled "Implementing Quality by Design" by Helen N. Winkle, Director, Office of Pharmaceutical Science Center for Drug Evaluation and Research Food and Drug Administration at the PDA/FDA Joint Regulatory Conference, Evolution of the Global Regulatory Environment: A Practical Approach to Change held on September 24, 2007