The pharmaceutical industry has relied on a system called batch processing as the standard manufacturing method for the last 50 years. Recently, advances in manufacturing technology have allowed for a switch to a faster, more efficient process known as continuous manufacturing.
NeuAge Institute provides a certificate program for students looking to go into the pharmaceutical industry, who need to gain a foundational understanding of the manufacturing process. Read on to learn more about the continuous manufacturing process and what it could mean for the future of pharmaceutical production.
Overview of the Continuous Manufacturing Process
The continuous manufacturing (CM) process potentially could create higher quality drug products while offering larger and more flexible batch sizes, as well as a smaller overall facility footprint. Although there is a broad definition of what pharmaceutical manufacturers and regulators consider a “continuous process,” the International Council for Harmonisation (ICH) has given three examples of CM.
The first is a hybrid approach that sees some operations in the batch approach and others running in a more continuous manner. The second is a process that makes all drug unit operations integrated and running continuously. And the third is the connection of both drug substances and drug products in an end-to-end continuous process.
Students at the NAI in our Pharmaceutical Quality Assurance program take an Introduction to Pharmaceutical Manufacturing Methods course, exploring important drug formulation and manufacturing concepts as well as various approaches and routes for drug delivery. Students can expect to gain an understanding of the entire range of available approaches to getting a pure drug into the body and to its therapeutic tissue target.
Benefits and Drawbacks of Continuous Manufacturing Pharmaceutical Certification Students Should Know
Possible benefits for continuous manufacturing are essential for students earning their pharmaceutical certification to understand, based on the industry shift toward these hard-to-resist advantages. Some benefits include significant technical, quality, and economical advantages, as well as a more efficient, safer, and greener synthesis route for production. Instead of these changes, NAI has designed comprehensive programs with industry and educational experts, giving students access to the current requirements and trends in the industry to ensure that students graduate career-ready.
A possible drawback of the continuous manufacturing process includes the lengthy work required to convert manufacturing plants to support this new process. While the FDA has specifically set out to develop regulatory standards, harmonize them with guidelines abroad and ease the entry of early adopters, many roadblocks remain such as time constraints, a new process design paradigm and equipment selection and design.
Methods for Adopting Continuous Manufacturing for Drugs
MIT showcased the first end-to-end continuous pharmaceutical process with automated, model-based control at the bench scale, proving that the hurdles are able to be overcome. Since then, six more drugs have been approved in the United States and abroad that integrate continuous manufacturing.
Because the certificate program at NAI provides knowledge and insight into the Quality Department of pharmaceutical and allied industries, with the main focus on Quality Assurance and cGMP, students will have a good understanding of the US-FDA and other global regulatory agency (Health Canada and European) compliance requirements. With such a solid foundation in industry knowledge, students are able to graduate ready to fill any position in a Quality Department.
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