The modular design philosophy can be applied from the design of an entire bioprocess facility down to the design of the individual unit operation in a bioprocessing train and even to the components that construct the equipment that these operations rely upon. It just depends on what your business needs are and where in that design journey you start. So, let’s back up a bit to where the story starts.
Traditionally, facilities made for bioprocessing started as stainless-steel based seed trains and purification in rigid, brick-built facilities with fixed infrastructures supporting these processes. These traditional designs performed their defined job well and have done what is asked of them for the past few decades. But the growth in bioprocessing has increased demand for a wider variety of therapeutics, for higher volumes as well as smaller volumes, all with increasing time and cost pressure. Bioprocesses have become more efficient through various intensification programs however this increase in the range of bioprocess volumes and variety of bioprocesses means that the growth can no longer be met by fixed facilities and inflexible equipment.
The growing move to ‘modular’ technology advances the future of biotherapeutics by designing in flexibility and reducing design and build times at all levels. Flexibility, delivered through configurability allows adaptation to changing markets, changing process needs and changing technology. It allows the rapid repurposing of assets, reducing capital investment and de-risking process development by using proven solutions.
Modular construction can be seen in many designs at all scales. A modular system can be at the facility level such as a prefabricated set of cleanrooms which can take just weeks to construct and integrate into a building shell. It can be custom built to the users’ needs, delivering the possibility of a fully cGMP compliant facility, ready in just a few months. With the right design and foresight, any such facility can accommodate a wide variety of different processes within its walls. The increasingly common ballroom concept fits well with a modular approach.
Modular design can also apply to the process contained within a facility. This can also be constructed from a set of process building blocks, each designed to deliver a specified unit operation and designed to connect to produce a fully integrated and automated process. This approach permits adaptation, by reconfiguring existing unit operations and adding new ones when necessary. A modular process-level solution enables proven operations to be selected, safeguarding performance, and reducing late-stage development problems that can delay the journey to critical milestones and manufacturing readiness.
Modular design is also seen at the unit operation level. Individual pieces of process equipment can themselves be made configurable to permit flexibility and adaptation to support different process needs. This feature makes them a desirable component within the process level modularity but also makes them valuable additions to an existing collection of process equipment, especially in multiproduct facilities.
Even the process equipment can be constructed from modular elements. These may be simple proven hardware subassemblies or components that are common to a wide range of operations such as valves, sensors pumps and automation hardware. They may also be software that can itself be modularized to work with different unit operations while maintaining security, compatibility, and usability.
What can be seen with all these types of modular solutions is the efficient planning and time saving designs that allow for drug manufacturers to delay investment. Reducing the construction time allows for the opportunity to defer costs for when there is more certainty of clinical trial success. A modular process design can provide the cost-effective solutions that can be desperately needed in times of rapidly increasing demand. Modular systems also offer benefits to the supplier, simplifying development and new system design by reusing proven components and knowledge. This accelerates availability of new process solutions as well as offering opportunities to safeguard the supply chain with the increased control and rationalization of process components.
Designing modular solutions allows for, and anticipates, change. They build in versatility through configurability and embrace flexibility without fear of compromise.
Whether you need a comprehensive set of nested modular solutions to cover everything from the facility to the individual components, or are just filling a process gap, a modular system is a great way to adapt to a growing market, to adapt to changing process demands and to prepare for future needs without compromising the needs of today. It allows you to design, build and operate in a time and cost-effective manner. It allows you to manufacture at your desired scale today and quickly scale up should the demand increase. It allows to balance the needs of today with the opportunities of tomorrow and is increasingly becoming part of the pathway that supports industry growth and all the life changing therapies and treatments that will protect and save lives.