Historically, manufacturers have used a ‘waterfall’ approach when designing and building their production facilities, sequentially resolving and specifying all aspects up front and in detail for each project, over and over again. These projects can take up to five years before reaching full operation and have an obsolescence risk because technology and solutions have often moved on by the time the project is completed. Even an agile project can take significant time to complete due to the number of inherent iterative design loops.
These traditional projects can be expensive to build and modify, and may be inflexible if they have to change to accommodate new products. A new approach and mindset are needed to change the way that manufacturing facilities are designed and constructed.
The BioPhorum Technology Roadmap Standard Facility Design working group has, therefore, stepped up to produce the Improving the Biomanufacturing Facility Lifecycle using a Standardized, Modular Design and Construction Approach white paper.
“The paper sets out to influence and align manufacturers, consulting engineers, suppliers and constructors around common terminology and definitions, as well as project execution methods that apply to the design and construction of biopharmaceutical facilities,” said Doug DeVeny, Global Technical Lead, Architecture/HVAC, Pharma Global Engineering at Genentech. “To reduce project timelines and costs, as well as increase the flexibility and lifecycle adaptability of facilities, moving towards more standardized, modular design and construction solutions is needed to meet the demands of the biopharmaceutical market.”
The paper proposes a standardized design approach, along with an example facility concept for a 2 x 2,000L monoclonal antibody (mAb) drug substance manufacturing facility, primarily utilizing a single-use technology platform.
The example solution can be used as a template for similar 2,000L-scale mAb projects or as a basis for new standardized facility templates for other applications. It discusses how a modular design approach may be realized using various construction methods – including traditional stick-built, prefabricated and skid assemblies, modular cleanrooms or complete modular building units – without needing major design reconfiguration.
The paper creates a vision of how a future biopharmaceutical manufacturing facility might look. So instead of starting with a blank piece of paper every time a new facility is needed, it recommends looking to standardization and a more modular approach to design and building. This would have many benefits, including faster use of a new facility, deferred capital expenditure, more rapid product launches as well as increasing a facility’s lifecycle by adapting it for different needs.
“The main benefit of the paper is that it highlights the distinction between modular design and modular construction, which is not well understood within the industry,” said Austin Lock, Technical Director & Deputy Pharmaceutical Sector Director at PM Group. “By using a single-use mAbs facility as an example, the paper identifies how a methodology, which incorporates both modular design and modular construction as core fundamentals, can be used to deliver a standard manufacturing facility, enabling significant benefits such a faster speed to market and reduced CAPEX.”
Publishing the white paper is the end point of a successful process, from the whole collaboration and overcoming confusion about terminology, to demonstrating that a modular and mobile facility is a viable proposition. One of the real achievements is that engineering firms have engaged in the process and not seen it as a threat to their design services; they can see how using it means they can provide better value to their clients.
The next step for the team is to consider the needs of cell and gene therapy facilities while applying the principles from the paper to develop another example of a facility concept. The team will also provide guidance on how to apply these standards in the set up of catalogs that can enable manufacturers to more easily and quickly select the components needed to design and build a facility.