Increased CGT demand could fuel demand for alternative cleanroom arrangements

The continued growth of the cell and gene therapy (CGT) market will increase demand for alternative cleanroom arrangements, predicts Ravi Samavedam, chief innovation officer at Azzur Group (Hatboro, Pennsylvania). “Keeping up with market forces will require an increase in demand for therapies that will outstrip current means of production,” Samavedam said. “Building facilities requires validation that can delay the manufacturing process while CDMOs are already operating at capacity. Neither alternative will satisfy growing demand.”

As a case in point, Charles River expanded its cell therapy CDMO facility in Memphis, Tennessee, earlier this month. Suited for clinical and commercial cell therapy manufacturing applications, the new space has nine new processing suites, adding to an existing 16 cleanrooms. 

Growing demand for CGT could drive similar growth across the sector. Worth $7.7 billion in 2021, the CGT market could reach $13.8 billion by 2026, according to the market research firm Research and Markets. 

The FDA also continues to approve a growing number of CGT products. 

Last week, FDA approved CSL Behring’s (ASX: CSL) Hemgenix (etranacogene dezaparvovec), an adenovirus-associated virus-based gene therapy for hemophilia B. By 2025, the agency anticipates that it will approve 10–20 cell therapies per year. 

Samavedam anticipates that the continued growth in the CGT sector will lead to increased interest in bridging the gap between building facilities or outsourcing capacity. “Bridge facilities will gain traction in 2023,” Samavedam predicted. “These so-called ‘bridge facility’ scenarios have yielded a variety of alternatives, including cleanroom licensing.” 

CGT companies are already deploying such bridge facilities in areas with the highest concentration of pharmaceutical and life sciences manufacturing. “Bridge facilities are becoming a cost-effective way for pharma manufacturers to scale their operations to meet demand without building facilities that may remain largely vacant,” Samavedam said. 

CGT and established pharmaceutical companies are also likely to rely increasingly on robotics and automation technologies in the coming years. Some companies plan on deploying such technologies, however, five to 10 years down the road, as an article in Business Facilities notes. Warehouses are poised to be especially quick in their embrace of automation. 

In the CGT market, companies like Cellares are looking to expand the role of automation to enable industrial-scale cell therapy manufacturing. 

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Filed Under: Cell & gene therapy
Tagged With: cleanroom
 

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