By Maik W. Jornitz and Sidney Backstrom
In the lifecycle of pharmaceutical and biopharmaceutical commercial manufacturing, the one constant has been change. With the advent of modern therapeutics, large scale commercial manufacturing became common place. And typically such manufacturing produced large scale purpose built facilities designed to satisfy “blockbuster” global demand. Inside those facilities, it was not uncommon to find re-usable stainless steel process equipment up to the 20,000L scale. Improvements in expression levels in mammalian cell culture processes and the continued and growing implementation of single-use process technologies, however, have dramatically changed the complexion of commercial manufacturing. 20,000L capacities are now in far less demand which has allowed the biopharmaceutical industry to evaluate smaller footprint cleanroom infrastructures in facility design projects. Demand for smaller, more flexible, manufacturing facility designs has been further accelerated by the need to produce in-country/for country and by advances in biosimilar technology, which requires multi-product processing capabilities. Furthermore, smaller environments can provide the containment required in the production of highly potent components and purely aseptic processes in cell therapy production. Smaller volume filling created the opportunity of new aseptic processing technologies, for example pre-sterilized container systems and robotic filling in isolators. These systems are so compact that one can think about drop-shipping needed filling capacity within a prefabricated environment in a flexible placement mode. Some of these smaller infrastructures have the further benefit of being able to be rapidly deployed thus reducing the time to first production runs and the resultant monetary benefits.
Once thought of as a “moonshot” future technology, these modular facilities are now replacing traditional methodologies the industry is also beginning to see architecture and engineering firms embrace this new technology in favor of or in addition to the traditional design build paradigm. Moreover, modular companies are starting to collaborate thereby enhancing their offerings, which could be the beginning of mergers and acquisitions in this arena similar to what has occurred in the process equipment space.