In manufacturing a biopharmaceutical product, almost every part of a typical process (such as monoclonal antibodies) has been significantly improved, but there have been surprisingly few great leaps of innovation in a 50-year history.
General wisdom may suggest that doing the same thing, in the same way, time and time again, may impede progress when compared to seeking the absolute best solution each time. There is no doubt that when applied blindly this may be true. But it may also be true that standardization can be the very catalyst required to permit, and to support innovation. It can also be true that standardization is the best solution.
In the context of biopharmaceuticals and the manufacturing process of a product, almost every part of a typical process, such as monoclonal antibody process for example, has been significantly improved, but there have been surprisingly few great leaps of innovation over their 50-year history. There are two examples that I would like to discuss as a vehicle to illustrate the power of standardization.
Firstly, cell culture process development to produce monoclonal antibodies, went through a period of experimentation but has mostly settled on the use of Chinese hamster ovary (CHO) cells. Every cell line used in the production of recombinant proteins and antibodies is unique, but the existence of a known platform solution and the application of an increasingly powerful set of gene editing tools means that creating a biological manufacturing engine is infinitely easier today than it was just a decade ago. This shows how a degree of standardization supports innovation elsewhere and accelerates the journey from the point of innovation (such as drug discovery in this case) to the point of realizing the value of that discovery (clinical production). Standardization in this context can be seen as a pre-made decision that leverages prior knowledge to accelerate the manufacturing process of a product and allow a focus on areas where the energy and attention add more value.
My second, and one of the more recent innovations, is the adoption of single-use manufacturing technology (SUT). This is not a single technology but a plethora of innovations and development that can be bundled together to support an entirely new manufacturing philosophy. Albeit one that largely mirrors the unit operations of the original reference manufacturing platform. The benefits of this manufacturing paradigm are well-discussed and new process developments almost always default, in some way, to such solutions. Standardizing on SUT has opened the door to more innovation and is the future of manufacturing technology.
SUT is intrinsically versatile and flexible. This is a huge strength but arguably a potential weakness also. To design a process from a blank page takes time. It also adds risk, with a vast set of variables interacting to the point where, without a close level of design control, they may lead to physical, chemical, or mechanical incompatibilities that could have an undesirable effect on the process. Here, standardization of a solution, has real value and controls this risk. Standardization in product design for components, reduces the variables and controls the risk with achievable sets of data to support these options. The real challenge is to create the right standards such that they do not limit the desired flexibility of the process. Similarly, systems that manage and control such solutions can benefit from standardization too. The right approach for both systems and consumables enable the flexibility required without an infinite amount of choice that introduces more risk than value.
Modular design approaches deliver a hybrid experience with all the value of standardization and, with the right pre-configuration choices, most of the value of customization. These values manifest themselves differently for consumables than for hardware. For single-use consumables this means reduced inventory and fewer product contact materials leading to more robust supply chain and easier regulatory compliance.
For hardware, modularization allows users to select systems with the features and specifications that are of most interest or of most relevance to the specific processes being supported. This also allows re-configuration to support multiple process needs from a single capital investment. This is especially valuable for multiproduct facilities and CDMO and, when combined with a number of multiple unit operations, enables the creation of a truly modular and versatile process much like those used by small molecule manufacturers.