Key Factors Involved in Designing Specialized Manufacturing Facilities for Cell-Based ATMPs: Layout, HVAC Requirements and Area Classification

This article explores critical aspects of facility design for cell-based advanced therapy ATMPs, emphasizing cleanroom classifications, requirements for Heating, Ventilation, and Air Conditioning (HVAC) systems, and contamination risk management across various stages of manufacturing. It highlights the importance of aligning these design elements with regulatory standards set by authorities such as the US Food and Drug Administration (US FDA), the European Medicines Agency (EMA), and the International Organization for Standardization (ISO) to ensure product integrity and patient safety.

The article also emphasizes the importance of biosafety containment, waste management, and scalable infrastructure to support diverse production needs. Modular design further enhances operational flexibility and regulatory adherence. By addressing these considerations, this article provides a comprehensive framework for designing of cell-based ATMP manufacturing facilities that meet both clinical and commercial demands, ensuring sustainable and efficient production while safeguarding product quality and patient safety.

Introduction

ATMPs that are derived from genes, cells, or tissues, provide targeted treatments for rare diseases and specific patient groups. In contrast to conventional biopharmaceuticals—small molecules or large-molecule biologics—ATMPs present unique manufacturing challenges that demand specialized facility designs.1

ATMP is transforming the healthcare landscape, offering curative potential for previously untreatable conditions. Unlike conventional biopharmaceuticals, such as monoclonal antibodies or recombinant proteins, which are produced in large-scale with well-established processes, ATMPs are highly complex and patient-specific often requiring intricate handling of living cells and genetic material. The facilities that handle these therapies demand flexibility, contamination control, and stringent regulatory compliance.2

ATMP facility design must accommodate unique production requirements while ensuring compliance with evolving regulatory frameworks. Unlike traditional biologics manufacturing, which benefits from standardized batch production and highly automated closed systems, ATMP production frequently involves open manipulations, small-batch or single-patient manufacturing, and customized workflows. These unique requirements pose significant challenges in facility layout, environmental control, and material flow management, necessitating advanced infrastructure solutions. This article focuses specifically on cell-based ATMPs, including both autologous and allogenic facility design considerations. In the context of this article, ATMP refers exclusively to cell-based advanced therapies, including both autologous and allogenic.

Facility Design Implications for Cell-Based ATMP Manufacturing

ATMP production involves handling highly sensitive biological materials, such as patient-derived cells, viral vectors, and gene-modified cells, all of which are highly susceptible to contamination.3 Even the slightest deviation in environmental conditions can compromise product efficacy, introduce safety risks, and lead to regulatory non-compliance.4^, 5 To mitigate these risks, facility design must integrate:

• Cleanroom Classifications and HVAC Systems

  ATMP manufacturing requires higher-grade area classifications for most of the production due to the open handling of biological materials. International Organization for Standardization (ISO) Class 5 is required for critical operations, with unidirectional airflow, HEPA filtration, and precise temperature and humidity control.

• Modular and Flexible Facility Layouts

  Unlike large-scale biologics production, ATMPs necessitate smaller, highly adaptable cleanroom suites to accommodate personalized and variable manufacturing processes. Facilities must ensure segregation of autologous batches to prevent cross-contamination, while allogenic production may require highly controlled, scalable processing spaces.

• Stringent Aseptic Processing and Containment Strategies

  Given the risk of cross-contamination and viral vector exposure, closed-system processing is preferred where possible, complemented by single-use technologies (SUTs) to minimize contamination risks and reduce cleaning validation burdens.

• Cryogenic Storage and Logistics Infrastructure

  ATMPs often require cryopreservation to maintain cell viability. Facility design must incorporate dedicated cryostorage areas, secure transport pathways, and robust inventory management systems.

Understanding Cell Based Atmp Product Types: Autologous and Allogenic

Before delving into facility design, it is essential to understand the differences between autologous and allogenic products:

• Autologous products are derived from a patient's own cells or tissues via apheresis, then modified and reinfused into the same individual (see Figure 1). Each batch is patient-specific, produced in small-scale volumes (up to 15L), and involves personalized manufacturing runs with a high degree of separation between batches6 and high levels of aseptic control. Production typically occurs in an isolator. There is no risk of immune rejection since the patient’s own cells are used (e.g., CAR T cell therapies).

Figure 1: High level overview of a typical autologous cell therapy manufacturing process

Allogenic products are sourced from donor cells or tissues, which may come from an unrelated healthy individual or a cell bank, enabling treatment of multiple patients from a single donor source. Cells with specific properties are propagated in controlled bioreactors (typically up to 200L). These products have scalable manufacturing with lower production costs and faster availability since products are pre-manufactured and stored for on-demand use.7 However, allogenic cells have challenges related to strict donor screening, cryopreservation requirements to maintain potency and potential immune rejection.

Both type of ATMP facilities involve distinct upstream and downstream processes depending on the modality. Upstream steps include material storage, cell collection (Patient/Donor), cell isolation expansion and differentiation. Downstream processes focus on harvesting, purification, formulation, aseptic fill/finish, and cryopreservation of the final product. In viral vector manufacturing, Upstream Processing (USP) involves cell culture and viral production, and downstream processing (DSP) includes viral purification, concentration, and formulation. Supporting operations, such as quality control, packaging, labeling, and waste management, ensure compliance, traceability, and product integrity.6^, 7

Facility design for cell-based ATMPs shares key elements with aseptic processing—such as cleanroom classifications, HVAC requirements, and contamination risk management. Unlike traditional aseptic processing, cell-based ATMP facilities must accommodate patient-specific (autologous) or batch-based (allogeneic) production, often requiring flexible facility layouts, rapid turnaround times, and stringent chain-of-identity controls. Additionally, ATMPs involve handling living cells, which introduces distinct contamination risks, biosafety considerations, and regulatory complexities not typically encountered in conventional aseptic manufacturing.

This article explores key considerations in facility design, focusing on contamination control measures, environmental management, and adherence to regulatory standards to patient safety and product integrity. These elements are crucial for meeting current Good Manufacturing Practice (cGMP) standards.

As the ATMP sector continues to evolve, facility designs must remain adaptive, scalable, and compliant with stringent regulatory standards, ensuring the seamless production and delivery of these revolutionary, life-saving therapies.

Key Regulatory Frameworks for ATMP Facility Design

Designing facilities for ATMP production must adhere to several global regulatory standards. Key guidelines include:

• Good Manufacturing Practice (GMP): ATMP facilities must follow the European Commission’s EudraLex Volume 4 Part IV,2 which specifically addresses GMP requirements for ATMPs, and similar regulations from the US FDA under 21 CFR Part 210, 211 and 600.8
• ISO Standards: For sterile environments, ATMP manufacturing facilities should comply with ISO 14644 for cleanroom classifications, which are necessary to maintain the required cleanliness levels. Both autologous and allogenic CGT facilities must comply with international standards such as ISO 14644.5
• Environmental Health and Safety (EHS): Stringent requirements exist for handling biological materials. Adhering to biosafety regulations such as Biosafety Level (BSL)- 2 or 3 ensures protection against hazardous biological agents.9
• Annex 1 of EU GMP provides critical guidance on sterile manufacturing.10

Understanding these frameworks helps ensure compliance while addressing facility challenges specific to product manufacturing.

Key Design Considerations for Autologous and Allogenic ATMP Facilities

A. Cleanroom Classification, Contamination Control and Airflow Design

Maintaining cleanroom environments is one of the most critical factors. Given the high sensitivity of biological products, particularly autologous therapies, contamination can result in batch failure or patient safety risks. Strict segregation is essential due to the patient-derived nature of autologous therapies and cross-contamination risks.

Designing cleanroom classifications and airflow control systems for autologous and allogenic manufacturing facilities requires careful consideration of contamination control, product safety, and regulatory compliance. Though both types of facilities share common principles, such as ensuring a contamination-free environment and adhering to strict regulatory standards, there are distinct differences driven by the nature of the products they manufacture.6^, 7

Different grades or classifications correspond to the level of cleanliness required for various stages of production, ensuring that environmental contamination risks are minimized8 (see Table 1). Cleanroom classes, ranging from ISO Class 5 to ISO Class,8 should be maintained based on the criticality of the product, processes, and level of exposure during manufacturing.6^, 7^, 10^, 11^, 15

Grade A (ISO Class 5) cleanrooms ensure the highest sterility standards, essential for processes like cell and viral vector processing and filling etc. Provided with Biosafety Cabinet (BSC) or isolators, Grade A environments provide ultra-clean air to protect product integrity and ensure patient safety during critical operations.

Grade B (ISO Class 7) serves as the background environment for Grade A areas where critical open operations are performed. These areas are integral to processes like cell processing etc. Materials prepared in Grade B areas are aseptically transferred to Grade A environments for critical operations such as final processing and primary packaging, maintaining the required contamination control throughout the workflow.

Grade C (ISO Class 8) areas are designated for less critical processes that require a controlled, clean environment. Grade C area includes activities such as initial material handling, preparation of intermediate products, and certain formulation steps where the product is not directly exposed to the environment. Grade C environments are commonly used for initial cell isolation and the preparation of components.

A Grade A zone is typically surrounded by a Grade B area. However, a Grade A zone can also exist in a Grade C background if it is fully enclosed, such as in isolators or closed Restricted Access Barrier (RABs) with Vaporized Hydrogen Peroxide (VHP) decontamination.

Grade D represents the lowest level of cleanliness in a cleanroom environment, primarily used for non-critical processes such as raw material and equipment storage. Although the air quality requirements are less stringent than in higher-grade areas, these spaces maintain controlled conditions suitable for non-sterile processes, material staging, and equipment storage before transferring items to higher-grade areas.

Autologous therapies, which produce patient-specific products, require smaller-scale production environments with stringent segregation to avoid cross-contamination between batches. Given the individual nature of each batch, these facilities often need multiple small, segregated cleanrooms or isolators, each equipped with dedicated air handling systems to maintain separation (see Figures 2 and 3). Isolators offer strong contamination control. However, regulatory agencies like the US FDA and European Medicines Agency (EMA) still require risk assessments for shared space use. The risk of cross-contamination is particularly high in autologous settings, making robust segregation and airflow control essential. This typically involves the use of unidirectional airflow and fully isolated HVAC systems to ensure that patient-specific processes remain distinct, and contamination is prevented.6^, 12 Allogenic therapies, which are derived from donor cells, enable the production of larger batches to treat multiple patients, supporting centralized and high-volume manufacturing. The facility design is tailored to accommodate large-scale operations, often mirroring biopharmaceutical setups with cleanroom environments. These larger rooms typically feature cascading pressure zones, where higher-classified clean areas (e.g., ISO Class 5) are positioned next to less controlled zones (ISO Class 7 or 8). Airflow management focuses on maintaining batch integrity. The design prioritizes efficient air handling systems to manage the airflow in larger spaces, with High-Efficiency Particulate Air (HEPA) filtration ensuring critical areas meet stringent air quality standards. Biological Safety Cabinet (BSC) technology is applied selectively, particularly over key process points like filling or open product handling7 (see Table 1).

B. Material, Personnel and Waste Flow

For both manufacturing types, the flow of personnel, materials, and waste must be meticulously controlled to prevent contamination, with operational requirements tailored to the specific nature of the products.13 This necessitates strict procedures for managing both personnel and materials throughout the facility. Cleanroom design plays a critical role in both cases, incorporating unidirectional movement with separate supply and return corridor, defined gowning protocols, and airlock systems to ensure product safety and quality. Personnel and material airlocks, gowning rooms, and buffer zones are critical design elements that maintain the separation between different cleanroom grades. Additionally, careful zoning and environmental control measures are essential to avoid cross-contamination, with distinct pathways for personnel and materials optimized to support regulatory compliance and operational efficiency. Personnel and raw materials should enter the facility through lower-grade areas (e.g., Grade D) and move progressively towards higher-grade areas as they are processed. 12^,  6^, 7

Autologous: Multiple smaller-scale production rooms or Isolators are typically required to accommodate each patient-specific product. These cleanrooms are designed to maintain unidirectional flows (see Figures 2 and 3), ensuring a clear separation between incoming materials (like patient-derived cells) and the outgoing final product. This helps to prevent cross-contamination and ensure product purity. Additionally, strict gowning procedures and airlock systems are implemented to protect both the operator and the highly sensitive product. Due to the personalized nature of autologous manufacturing, each product batch is handled in isolation based on the outcome of risk assessment.6

Allogenic: In contrast to autologous, allogenic manufacturing allows for larger-scale and more centralized operations. Facilities for allogenic products are designed to handle bulk raw materials and process larger batches simultaneously. Instead of isolated cleanrooms for each batch, shared production spaces are used, with strict segregation achieved through cleanroom zoning. The workflows are more streamlined, with bulk material handling in larger preparation rooms and downstream processing taking place in common spaces. This allows for more efficient production compared to the individualized approach of autologous manufacturing.7

Figure 2: An example of an ATMP Facility Design

Figure 3: An example of an ATMP Facility Layout

Waste management in such facilities is a crucial aspect of maintaining operational efficiency, mitigate contamination risks, regulatory compliance and product integrity. Effective waste management includes dedicated waste streams, decontamination, secure disposal, and licensed vendors. Dedicated material flow corridors (see Figure2) or segregated pathways for waste and process materials enhances these measures streamline waste handling, ensure controlled material movement, and minimize cross-contamination risks in facilities while adhering to cleanroom standards. Compliance is maintained through records, audits, and validated inactivation. If a unidirectional flow is not incorporated into the design, waste management must be meticulously controlled through strict time-based scheduling to prevent cross-contamination and ensure compliance with regulatory standards. Before beginning the design process, the team must understand the types of waste that will be generated and handled within the facility. Waste needs to be carefully segregated based on its classification such as hazardous (chemical, biological) and non-hazardous (general office waste and packaging). The complexity of ATMP processes generates multiple waste streams, including solid waste, biohazardous waste, and liquid effluents as part of its operations. However, the type and volume of these waste streams can vary significantly depending on the facility’s processes, product types, and scale of manufacturing. Each waste type requires tailored handling and disposal protocols. For example:

• Solid biohazardous waste can be decontaminated by different methods e.g. via heat (autoclaving and incineration) followed by disposal method. Waste must be stored in properly labeled and secured containers to prevent contamination and facilitate efficient removal.
• Liquid biohazardous waste, such as viral vector residues or cell culture media, requires inactivation—via chemical, thermal, or other methods—before discharge into municipal systems.

The approaches to waste management must be tailored to the facility’s scale, process specifics, and regional regulations. Compliance with regional biosafety standards, which may vary between jurisdictions, such as in the United States and European countries, is essential. Biosafety level (BSL) classifications, ranging from BSL-1 to BSL-4, dictate the stringency of containment and treatment measures required. No universal waste management approach suits every ATMP facility. Instead, waste handling systems must be customized based on process requirements, facility size, and regulatory obligations.6^, 7^, 9 For small-scale ATMP operations, outsourcing waste collection and processing to external vendors can often be more economical. These facilities should include designated staging and pickup zones, appropriately sized to accommodate waste accumulation based on scheduled pickup intervals. In contrast, large-scale facilities may find it advantageous to implement in-house waste processing systems, necessitating the design of centralized infrastructure capable of managing diverse waste streams.

C. Biosafety Containment

Biosafety containment is also a critical pillar of facility design given the significant risks associated with handling gene-modified cells. A BSL rating is different from a room environment (cleanroom) classification. The room cleanliness class is related to product exposure and not to the biosafety level.

Biosafety Levels (BSL) 1–4 classify environments based on biological risk. In autologous and allogenic facilities, BSL-2 and BSL-3 are most relevant:

• BSL-1 (Low Risk): Basic labs for non-hazardous cell cultures.
• BSL-2 (Moderate Risk): Used for primary human cells and viral vector preparation.
• BSL-3 (High Risk): Requires containment measures for large-scale viral vector production and gene editing.
• BSL-4 (Maximum Risk): Rarely needed in such type of facilities

A comprehensive biological risk assessment at the project's outset is essential to evaluate potential risks to personnel and the environment.9^, 14

Autologous facilities typically comply with BSL-2 standards. With containment requirements , maintaining strict aseptic conditions is also vital to prevent contamination and ensure product sterility and patient safety. In contrast, allogenic facilities face greater biosafety challenges due to the risk of cross-contamination between different donor cell batches. Additionally, the use of viral vectors or gene-editing technologies introduces specific contamination risks, such as adventitious agents and cross-contamination (rather than widespread viral shedding). To mitigate these risks, advanced biosafety protocols, such as BSL-2 or BSL-3 containment are often required. Both facility types underscore the importance of robust biosafety measures to ensure product integrity, protect personnel, and safeguard the environment.6^, 7

D. HVAC Requirements

In addition to cleanroom grading, the HVAC system plays a critical role in maintaining the desired environmental conditions throughout the facility. Air Handling Unit (AHU) zoning divides a building into different areas, each served by a AHU or section of a system to optimize climate control, energy efficiency, and occupant comfort. AHU systems should be designed to support multiple zones within the facility, each corresponding to a different cleanroom grade. Each zone should have its own dedicated AHU system or subsystem, such as separate extract units, ductwork, ventilation controls, to ensure independent operation and prevent cross-contamination between areas. The airflow system must be designed in accordance with Good Manufacturing Practice (GMP) guidelines, particularly EU GMP Annex 1, FDA, and ISO 14644 standards.

ATMP facilities rely heavily on aseptic processing and the HVAC systems. These systems utilize high efficiency filtration system, up to and often including terminal HEPA filtration to minimize the ingress of contaminants into processing areas. HVAC systems control air quality, temperature, humidity, and pressure differentials, ensuring that cleanrooms operate within their specified cleanliness levels and reducing the risk of contamination.5^, 6^, 7

Key Factors That Influence the Ahu Requirements

Airflow and Pressure Differentials

Airflow Grade A (ISO 5): Unidirectional airflow with high air change rates. This is critical for processes that involve open manipulation of sterile products. BSC and isolators are used to achieve this level of cleanliness.

Grade B (ISO 7): Non-unidirectional airflow with air changes typically in the range of 50–60 ACPH.

Grade C (ISO 8): General processing areas in the range of 20–40 ACPH.

Grade D (ISO 8 at rest): Support areas with typical 10–20 ACPH.

Air Changes Per Hour (ACPH): The rate defined as the number of times the total volume of air within the cleanroom is replaced per hour. ACPH are specified based on multiple factors heat load, moisture load, no of personnel, gowning, process etc.

Pressure differentials: Pressure differentials between rooms of different grades help to prevent the flow of contaminated air from lower-grade areas to higher-grade areas. For example, Grade A and B areas are maintained under positive pressure relative to adjacent lower-grade areas (such as Grade C or D), ensuring that clean air flows outward and preventing contamination from entering critical spaces.

Cascading pressure differentials (maintaining higher pressure in cleaner areas) regulate airflow, ensuring controlled environmental conditions. In most cases, pressure control in cleanroom environments is primarily designed to protect the product by preventing contamination ingress. However, in Biosafety Level (BSL) laboratories, the approach can change depending on the containment level. For BSL-3 and BSL-4 facilities, pressure control shifts to protecting the operator and the surrounding environment by maintaining negative pressure to contain hazardous biological agents. So, while product protection is the priority in GMP manufacturing, at higher BSL ratings, the focus may shift towards operator and environmental safety. Negative pressure (based on type of operation and risk assessment) is utilized in some critical areas like viral vector production and BSL areas to effectively contain biohazards within the zones.

Air Filtration

HEPA filters are used in the facilities to remove particulate contaminants from the air. HEPA filters are required for all critical areas like Grade A, Grade B and Grade C these are essential for maintaining the cleanliness levels required in ATMP production.

A risk assessment should be utilized to verify if a particular process or product requires HEPA filtration of the supply or exhaust.6^, 7

Recirculation and fresh air: To maintain the required cleanliness levels, cleanrooms utilize either a recirculated air system or a once-through system, depending on contamination risk and process requirements. These systems incorporate a controlled supply of fresh air, with Air Changes Per Hour (ACPH). The required ACPH rate varies based on the cleanroom grade, ensuring optimal contamination control and compliance with regulatory standards.

The key driver for selecting one over the other is cross-contamination control.

• When to use once-through: Critical environments (e.g., Grade A/B cleanrooms for aseptic processing) often require once-through air to prevent the risk of recirculating contaminants. Highly sensitive processes benefit from this approach despite higher energy demands.
• When to use recirculation: If contamination risk is lower and proper filtration is in place, recirculation can be used to reduce HVAC energy consumption. Areas often incorporate recirculated air with HEPA filtration, balancing cleanliness and efficiency.

Temperature and Relative Humidity Control

Consistent temperature and relative humidity control are critical to preserving the integrity of biological materials in facilities. Temperature fluctuations can negatively impact the viability and potency of sensitive materials such as cell cultures and viral vectors. Cleanrooms typically maintain a controlled temperature range of 18-22°C, tailored to the specific needs of the process.6^, 7

Equally important, relative humidity (RH) levels are carefully managed to prevent microbial growth and ensure product stability. In most ATMP cleanrooms, RH is maintained below 60%, with stricter controls applied for certain processes, which may even require lower humidity levels.6^, 7

While these temperature and humidity settings also contribute to operator comfort during gowning, product-specific requirements take precedence if the product’s temperature is dependent on the room conditions, ensuring the optimal environment for both process efficacy and product preservation.6^, 7

Monitoring and Control Systems

Real-time monitoring: These monitoring systems can either be integrated with the HVAC system or operate independently to continuously track air quality parameters such as temperature, humidity, pressure differentials, and particle counts. Any deviations from predefined specifications can trigger alarms, allowing operators to take immediate corrective actions to prevent contamination.

Redundancy and backups: Given the critical nature of the manufacturing process or product, HVAC systems must be designed with redundancy to prevent operational downtime and ensure compliance with stringent regulatory requirements. Redundant AHUs play a crucial role in maintaining environmental conditions, such as temperature, humidity, and differential pressure, in case of primary system failure. These backup AHUs should be capable of seamless integration with the primary system, allowing for automatic switchover without disrupting classified cleanroom operations. In addition to AHU redundancy, backup systems, including independent power supplies and emergency control mechanisms, should be incorporated to mitigate risks associated with equipment failure or power outages. Monitoring and predictive maintenance strategies should also be employed to proactively identify potential failures and ensure a continuous, contamination-free environment for manufacturing.

Flexibility and Scalability

One of the significant challenges in ATMP facility design is creating a flexible and scalable infrastructure that can accommodate both autologous and allogenic manufacturing, given their distinct requirements. Modular cleanrooms and isolator technology can help in achieving this.

Modular Cleanrooms

Incorporating modular cleanroom designs is a practical approach that enables facilities to efficiently adapt to the varying production needs of autologous and allogeneic therapies. These cleanrooms can be reconfigured more easily, allowing for flexible layouts, rapid scaling from clinical to commercial manufacturing, and streamlined compliance with regulatory requirements, ultimately enhancing operational efficiency and cost-effectiveness.

Isolator Technology

Use of isolators is becoming increasingly popular due to their ability to segregate production zones and minimize contamination risks but don’t eliminate the need for robust risk assessments, facility design considerations and regulatory compliance. These systems are particularly beneficial for autologous products, where each patient’s product must be manufactured in isolation from others. For allogenic, it is best for sterility-critical steps.

Storage and Logistics

ATMPs require cryopreservation to maintain their viability until administration. Facilities must incorporate appropriate storage conditions based on the specific requirements of the process and materials. Cryostorage typically involves temperatures below -150°C, often achieved with liquid nitrogen systems. Facilities must include redundancy in refrigeration/cooling systems, continuous temperature monitoring with alarms, backup power supplies, and environmental controls to ensure uninterrupted operations and compliance with regulatory standards. Additionally, robust validation and documentation practices are essential for meeting GMP requirements and ensuring product safety.

Storage solutions vary by product type. Autologous therapies, being patient-specific, require smaller units with individual compartments to securely store and quickly retrieve personalized products. Allogenic therapies, designed for multiple patients, demand large-scale, high-density storage systems with reliable inventory management for batch release. Both types require precise temperature control, traceability, and contingency planning to mitigate risks like temperature excursions or equipment failure, ensuring the quality and integrity of these sensitive materials.6^, 7^, ,1

Facility Program

A critical aspect of facility design is the development of a comprehensive facility program. This program is determined by the type of product, the type of operations being performed and the number of patient batches operating within the manufacturing space. By utilizing details from Block Flow Diagrams (BFD), Process Flow Diagrams (PFD), Mass Balance Calculations, Scheduling and Capacity Planning, Facility Fit Assessment etc., the anticipated number of concurrent patient batch operations per room size can be clearly defined. This information is vital for establishing an effective patient segregation strategy.

A well-structured facility plan must be created to serve as the foundation for layout development. Table 1 provides an illustrative example of a room program, highlighting critical areas for different types of ATMP facilities. It outlines room classifications and Biosafety Levels (BSL) based on risk assessment outcomes. Additional factors, such as room size and other operational considerations, can also be incorporated into the program.

Table 1: An example of Room Program

Conclusion

A well-designed ATMP manufacturing facility is the cornerstone of safe, scalable, and compliant production. Balancing regulatory adherence, contamination control, and operational efficiency is essential to maintaining product integrity and patient safety. Tailored facility designs for autologous and allogeneic therapies, along with effective HVAC strategies, modular cleanrooms, and automation, ensure flexibility and future readiness. As ATMPs continue to shape the future of medicine, integrating cutting-edge technologies and strategic facility planning will drive efficiency, accelerate innovation, and ultimately improve patient outcomes.