Originally published on Future of BioPharm blog
There have been many improvements made in biopharmaceutical manufacturing since its inception in the 1980’s. This has culminated in the most common approach to large-scale biopharmaceutical manufacturing being the fed-batch mode applied to suspension culture. Improvements made to the process have involved each of the individual steps, including advances in cloning and selection methods, removal of animal products materials, implementation of single use systems and improved purification resins and columns. This isn’t to say that other approaches haven’t been tried, even with great success. For example, Genzyme (Sanofi) and Centocor (J&J/Janssen ) have long employed perfusion culture in upstream processes of some approved biopharmaceutical manufacturing. Nevertheless, the overall paradigm of batch-fed process throughout the industry has not evolved a great deal.
While batch-fed process is still by far the most popular choice for biopharmaceutical production, recent studies signal that this may be changing.Recently here was an article in the MIT Technology Review titled “Biotech Firms in Race for Manufacturing Breakthrough,” which described how Biotech firms including Genzyme and Amgen are actively pursuing radical new technologies to improve and streamline biopharmaceutical manufacturing. This kind of major change to biopharmaceutical production is critical if biotech firms are expected to maintain reasonable drug costs and continue to improve upon current productivity levels. Biotech firms and industry leaders are looking for ways to advance biopharmaceutical manufacturing to the next level.
One technology being explored in-depth is the system-wide use of continuous processing (CP). The concept of CP is certainly not new, and is the mainstay in such other industries as steel manufacturing to paper production. In continuous processing, as the name suggests, manufacturing is conducted in one continuous process where raw materials constantly flow in and out of manufacturing equipment and are continually processed into an intermediate or final product. In biopharmaceutical manufacturing this is accomplished in a bioreactor. This is in contrast to the discontinuous “batch” production, where a specific quantity of drug is produced in a single, discrete volume during the same cycle of manufacture. The episodic batch production mode is frequently segmented into many individual steps that are often performed at separate facilities (suites, buildings or cities). In continuous processing, on the other hand, production occurs at a single location, without interruption. In CP, manufacturing is conducted with more automation and fewer human operators. It has proved a very successful approach in a number of businesses, such as in the manufacturing of foods from catsup to cookies.
This industry proudly promotes their severely linear factories where materials are continually trucked in at one end of the factory, and product out the other. It’s really quite fascinating to see dough constantly assembled in the front of the plant, cookies baked in a long linear oven, cooled on a conveyer belt, and finally boxed and shipped out the back without pause or interruption. Read more
This industry proudly promotes their severely linear factories where materials are continually trucked in at one end of the factory, and product out the other. It’s really quite fascinating to see dough constantly assembled in the front of the plant, cookies baked in a long linear oven, cooled on a conveyer belt, and finally boxed and shipped out the back without pause or interruption. Read more
