Engineering Angles: Facility innovation in times of crisis
During a time when clinical research is extremely important in driving new therapies and vaccines to market, one particular segment of those studies — cell and gene therapy (CGT) — has come into focus. While some CGT companies have been able to avoid the economic downturn brought on by COVID-19, in many areas, research for allogeneic medicine has been turned upside down.
In order to support the life-saving work involved in developing precision medicines, R&D facilities must be fundamentally reimagined. The same advancements that have led to breakthroughs in allogeneic therapies have also brought on specific requirements that impact lab designs. Combined with COVID-related challenges, clinical research spaces are evolving to meet the demand for new therapies to be brought to market quickly.
Delays and challenges
The past year has presented many barriers to ensuring precision treatments are developed efficiently. In a recent study, one-third of CGT companies reported manufacturing delays, while one in five cited supply chain disruptions. Travel bans and restrictions on air transport have also been contributing factors to delays during the pandemic, but some centralized facilities have also shut down to prevent the exposure of cell donors and staff to COVID-19.
Though pandemic-related issues are a limiting factor in progress, the very nature of clinical development of personalized medicines is tied by requirements that affect the design of facilities. Because these treatments are based on specific medical characteristics of the patient, diagnostic testing must take place during drug development. These diagnostics require sophisticated testing equipment and will determine how products will be created. As opposed to traditional R&D spaces, research facilities for personalized medicines are relatively compact and leverage robust digital capabilities.
Redesigning facilities
Whether the facility will be targeting a patient-specific therapy versus an off-the-shelf allogeneic therapy is a major factor in determining the design requirements and process equipment for facilities. Automation requirements and equipment selection also vary according to the specific therapy. Allogeneic therapies that involve the harvesting and transplanting of cells require bioreactors, viral vectors and automation processes. Patient-focused therapies still rely on manual cell harvesting, bioreactors, incubators and manual production.
Support spaces for different therapies could be shared and designed accordingly, including areas for quality control, processing and storage. By creating these types of campus settings, all drug research efforts can benefit from using shared infrastructure and resources.
We’ve also been observing smaller-sized single facilities being utilized for patient-focused therapies, which require less warehouse storage (WH) space requirements because they are closer to the therapy locations for patients and require no stocks, like drug therapies. The challenge of CGT then becomes calculating the supply and demand, future-proofing facilities, and acknowledging the differences between therapies. This is typically accomplished by tracking the development of treatments from start to finish by utilizing AI technology and incorporating digital infrastructure in all facilities.
How is this impacting the space planning and real estate needs for personalized medicines? The market is moving towards pods in a WH setting in single buildings with smaller capacity that are closer to the patient cell harvest areas. R&D and QC labs with less complicated WH spaces also enable flexibility and future expansion. So, it is critical to consider the best investment strategies for locations, the advantages of existing or new ground-up facilities, and the benefits of pod or stick-built cleanrooms, as well as selecting manufacturers for large equipment.
The last year has seen a perfect storm for the development of allogeneic and autologous therapies. The coronavirus itself created a major health crisis that required personalized medical treatments to help people who were sick.
But even before the pandemic struck, because of the sensitive nature of making these therapies, pharma facilities needed to have enhanced measures in place to prevent contamination. These compounding issues make a strong case for building facilities that can weather any short-term or long-term crisis.
