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Over the past decade, Cell and Gene Therapy (CGT) has become one of the fastest growing areas in the science and technology sector. Today, investment and resources for CGT are generally strong; however, the primary challenge lies in effectively designing the spaces that support CGT operations. These are high-stake environments where a single batch can cost over a million dollars.
After working on CGT projects across the country, we’ve seen what works, what doesn’t, and what catches our clients by surprise. Here are three things that every team needs to know.
Most people start with the question, “What cleanroom grade do we need?”, and for many science and technology projects, this is a good question to ask. However, CGT facilities work differently: the manufacturing steps determine how the space is designed, not the other way around. In CGT manufacturing, the first question should be, “Which steps of this process can stay closed?”.
What is the difference? Our blog here outlines what each is and when to use them. The bottom line? Understanding when to use each allows teams to build manufacturing spaces that are efficient and scalable as needs change.
Air handling is one of the biggest cost factors in CGT environments. If a process is closed, it’s safe to reuse the air already conditioned in the room, meaning far less energy is required.
If a process is open (especially when viral vectors are involved), it’s forced into 100% once-through air, which is energy intensive and requires larger equipment. Closing a few targeted steps can significantly reduce HVAC loads. Closing processes is both safer and can be a major win in energy and cost reduction.
For more detail on the difference between open and closed processes, this article breaks down what each means and when to use them.
Compliance in CGT facilities exists to protect the product, the patient, and the manufacturing environment. Smart contamination control is how spaces achieve that compliance in a practical, efficient way.
When contamination control is well designed through closed processes, proper airflow, and right-sized cleanrooms, the space will naturally meet regulatory requirements and simplify operations. That simplicity reduces cleaning time, lowers HVAC demand, and makes switching between products easier.
Compliance doesn’t add cost; poorly designed contamination control does.
CGT manufacturing is only going to get bigger, and the facilities that succeed will be the ones who design around process. As therapies move from early clinical trials toward commercial-scale production, flexibility and contamination control will become more critical. The spaces built today need to support current operations while also allowing manufacturers to adapt as processes evolve and regulatory expectations continue to mature.
To discuss how you can improve your manufacturing process and save on costs, email me at rdoyle@wbengineering.com.
