Key Differences Between Traditional and Advanced Therapy Manufacturing Facilities

The healthcare landscape is evolving, with emerging diseases and innovative treatments reshaping pharmaceutical and biotechnology manufacturing. This shift has led to the adoption of advanced therapies such as cell therapy, gene therapy, and CAR-T therapy. 

These groundbreaking treatments require specialized manufacturing environments that differ significantly from traditional facilities designed for chemical and biological drugs. 

Comparing Traditional and Advanced Therapy Manufacturing Facilities

1. Product Nature 

Traditional manufacturing facilities produce standardized chemical-based or biological drugs. The primary objective is high-volume output to cater to global healthcare demands.  The processes are in a repeat mode to ensure consistency across batches.

In contrast, advanced therapy facilities create living cell-based therapies that can be highly variable depending on the patient’s cells. The production is small-scale and accommodates the unique needs of each batch, particularly for autologous therapies derived from the patient’s cells.

2. Process Complexity

Traditional manufacturing relies on well-established, relatively simple processes such as chemical synthesis or biologic fermentation, while therapy manufacturing involves intricate steps for the complex manipulation of cells and genetic material, such as cell isolation, modification, and expansion. 

Complex procedures such as viral vector production, electroporation, and aseptic handling of live cells also require specialized equipment and advanced techniques.

3. Production Scalability and Flexibility

Traditional facilities are optimized for scalability. Their operation relies on standardized equipment and processes to enable cost-efficient mass production. The scale-up strategies for gene therapy biomanufacturing emphasis replicating identical batches with minimal variability. 

Read more: Advanced Cell and Gene Therapy in Cleanroom Systems: Ensuring Precision and Safety

On the other hand, the smaller production scale and personalized nature of treatments in cell and gene therapy manufacturing require exceptional flexibility. These facilities are designed to handle multiple production streams simultaneously while maintaining sterility and preventing cross-contamination.

4. Cleanroom Systems Design and Contamination Control

Cleanrooms in traditional pharmaceutical facility design meet general cGMP (current Good Manufacturing Practices) requirements for large-scale production of chemical or biological drugs. Contamination control measures are effective for large-scale processes.

For therapy facilities, high-performance cleanrooms for CAR T-cell therapy and advanced cleanroom technologies for gene therapy production are employed to maintain stringent contamination control. 

This is often achieved through modular cleanroom designs or isolator-based setups that allow the segregation of production spaces. Such designs prevent cross-contamination between patient-specific batches and maintain sterility during sensitive processes involving live cells and genetic material.

5. Equipment and Technology

The biomanufacturing technologies in traditional facilities are designed for bulk production such as large bioreactors, mixing tanks, and automated filling lines. 

These systems are optimized for efficiency and throughput. Therapy facilities require specialized equipment, such as cell culture systems, viral vector production suites, and cryopreservation units.

Technology transfer considerations for gene therapy manufacturing include automated cell isolation, genetic editing tools, and single-use bioreactors are essential for supporting the precise and delicate nature of the therapies.

6. Personnel Practices and Training

In traditional pharmaceutical manufacturing facilities, personnel follow standard operating procedures (SOPs) designed for uniform operations. The focus is on maintaining consistency across batches through routine processes.

Facilities built for cell, gene and Cart-T therapy require highly trained personnel capable of handling complex and patient-specific operations. Personnel must be adept at aseptic techniques and familiar with cutting-edge technologies, as even minor errors can compromise the therapy’s safety and efficacy.

7. Regulatory Compliance

Both types of facilities must comply with cGMP regulations. However, the therapy facilities face additional regulatory scrutiny. Handling live cells and genetic material requires strict adherence to guidelines to ensure product safety, efficacy, and traceability. Regulatory frameworks often emphasize the chain of custody, chain of identity, and robust documentation.

8. Time Sensitivity

Traditional manufacturing processes often have longer production timelines that facilitate bulk storage and distribution of stable products.

In therapy facilities, time is critical. Processes must be completed within strict timelines to preserve cell viability and ensure the therapy’s effectiveness. This requires precise scheduling, efficient workflows, and rapid logistics.

9. Storage and Logistics

Traditional facilities focus on managing larger inventories and distribution of stable, shelf-ready products. These products are often transported at ambient or controlled temperatures.

In contrast, therapy facilities rely on cryopreservation to store living cells or genetic material. Logistics involve specialized containers and real-time monitoring to maintain ultra-low temperatures during transport, ensuring the integrity of the product.

Fabtech Adaptation: How FAB FITS! 

Whether supporting traditional pharmaceutical facilities or advanced therapy manufacturing, Fabtech delivers cutting-edge solutions with precision, efficiency, and quality.

From air, water, and process systems to turnkey engineering solutions, Fabtech enables traditional manufacturing facilities to achieve high-volume, cost-effective production. Simultaneously, we support cell and gene therapy facilities in meeting the industry’s demands for flexibility, sterility, and personalized treatment production.

The shift toward personalized medicine has driven the need for innovative and efficient facility layouts for cell and gene therapy production and engineering solutions. 

As the industry evolves, Fabtech remains committed to advancing groundbreaking therapies through turnkey pharmaceutical engineering solutions, ensuring their safe and efficient delivery to patients worldwide. 
Partner with Fabtech to build state-of-the-art pharmaceutical and advanced therapy manufacturing facilities. Contact us today to discuss your project.