Continuous Manufacturing for the Pharmaceutical and Biotech Industries
Today most pharmaceutical and biotech manufacturers utilize batch processes to produce APIs, biologics, and drug products. A batch process is inherently less efficient, more time consuming, and more costly than continuous. Batch inefficiencies are primarily due to the "start-stop-inspect" sequence of operations required to ensure that the products being manufactured are in full compliance with their quality specifications.
Continua Process Systems was formed in 2014 to create real-time continuous manufacturing software and solutions for pharmaceutical and biotech manufacturers to consistently produce drug products to pre-defined and measured Critical Quality Attributes (CQA) and Critical Process Parameters (CPP) more efficiently, faster, and of better quality than traditional batch methods.
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 your process 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