Leveraging design to minimize risk

Learn how the application of best practice design principles can help mitigate the risks confronting biotechnology companies when navigating the uncertainty surrounding the demand profile of its product pipeline.


Learn how the application of best practice design principles can help mitigate the risks confronting biotechnology companies when navigating the uncertainty surrounding the demand profile of its product pipeline. Courtesy: CRBBiotechnology companies are consistently looking for ways to reconcile an uncertain demand profile created by an ever-changing product pipeline against an existing manufacturing capacity. Because only a small fraction of products ever make it to market, biotech manufacturers must find ways to minimize their risk by deferring their investment in additional capacity until absolutely necessary.

Once an investment in capacity is deemed necessary, the company must maximize its return on investment (ROI) by creating a long-term functional business asset. One way to do this is to invest in flexible, adaptable, and scalable manufacturing facilities that can meet production demands across a platform of manufacturing technologies.

Designing a facility to meet production requirements isn't a simple proposition when confronted with uncertainty in product demand. When you factor in this uncertainty across potential product indications and layer it across different pipeline candidates at various stages of approval, the result can be substantial business exposure. However, there are some key design principles to keep in mind when designing a manufacturing facility and its infrastructure to support a great deal of flexibility and minimize risk. They include:

Analyze process closure. Based on the type of manufacturing process that will be employed (i.e., sterile, bioburden-controlled process, etc.), it is possible to quantify the risk that a given connection point in the process poses to the integrity of the manufacturing batch. The key is to design the system such that potential points of ingress are adequately protected with engineering solutions commensurate with the requirements of the process itself. It is critical to conduct a rigorous risk assessment of the process closures to provide a primary barrier against the risks of contamination or cross-contamination, identifying the appropriate environmental conditions for housing the process. Designing for process closure should minimize the surrounding clean room environment, allowing more efficient use of space by eliminating unnecessary airlocks and circulation space while permitting concurrent manufacturing of different products within a common ballroom.

Formulate the boundaries of facility capabilities. Variation in the manufacturing process may be introduced into a company's product pipeline from a variety of sources: internal process development, product acquisition, introduction of disruptive technologies, etc. In an ideal world, all commercial processes would be developed on a well-characterized platform of technology, but that is not the reality of today's manufacturing climate. While it's impossible to predict all possible variations that may be introduced, it is possible to identify the boundaries around a subset of the most impactful parameters that characterize a process, such as titers, yields, resin-binding capacities, etc.

It is critical to align the timelines for process development and facility construction to account for technology improvements that are realizable in the short term and can impact the facility design. It is also critical to assess potential variations in the manufacturing process across products to define the boundaries of the facility's capabilities. A truly flexible business asset (manufacturing facility) should have the capability to be turned down to run at a different capacity to be of the greatest value supporting the company's biological supply chain.

Take a holistic approach. Investing in a manufacturing facility requires a significant commitment of capital and human resources to develop into a long-term business asset. For this reason, the master plan for the campus and internal organization of spaces within its facilities should be designed to adapt to the potential changes in projection of the product pipeline. Spaces housing potential bottlenecks in the manufacturing process can be prepositioned to permit easy expansion or addition of equipment that would enable future changes or adaptation for different platform technologies. Similarly, design of the utility systems should permit easy capacity expansion or extension to new manufacturing areas. Recognizing the impact of potential expansion to other supporting functions, such as administrative, laboratories, and warehouse, are equally critical to providing a truly flexible business asset.

Matthew Kennedy is process engineer at CRB’s Philadelphia office. Courtesy: CRBMatthew Khair is process engineer at CRB’s Philadelphia office. Courtesy: CRB

Align technology choices with business drivers. As single-use technology develops, its adoption increases, and innovators and early adopters prove it out, it will be critical to both assess its potential business risks and understand where to strategically implement the technology within the manufacturing process to align with cost of goods. While the benefits of this technology are well-publicized (reduction in utility demands, facility footprint, speed to market, improved turnaround time, etc.), a flexible manufacturing facility must be designed to align with the business drivers behind its inception from day 1. Wholesale adoption of single-use technology by a late adopter whose business systems may not be set up to contend with the strains it can put on an organization's supply chain management, operations, validation, and quality groups can have disastrous repercussions. That being said, a flexible manufacturing facility is not necessarily a single-use one.

Prudent application of the best-practice design principles outlined here can help to mitigate the business risks confronting a biotechnology company facing an investment decision while trying to navigate the uncertainty surrounding the demand profile of its product pipeline. Leveraging these design principles allows biotechnology companies to minimize their supply chain risk and provide a flexible, valuable asset to align with their long-term manufacturing goals, thus providing a strong ROI.

-Matthew Kennedy and Matthew Khair are process engineers at CRB's Philadelphia office. This article originally appeared on www.crbusa.com. CRB is a CFE Media content partner.

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