Advanced therapy medicinal products (ATMPs), a class of therapies including gene, cell, and tissue-engineered therapies, offer the potential for treating a wide variety of diseases, from rare genetic disorders, to various forms of cancer, to neurological conditions and metabolic disorders.
ATMP manufacturing requires stringent cleanroom controls. Contamination control, through containment strategies and specific environmental conditions, is paramount due to the intricate processes, sensitive material,s and handling of patient cells and tissues often involved in ATMP production.
In particular, the operational challenges and potential manual processing steps in cell and gene therapy (C>) production, both autologous and allogeneic, introduce unique cleanroom design requirements.
Autologous therapies require cleanrooms that support patient-specific workflows
Autologous therapies require cleanrooms that support patient-specific workflows and minimise cross-contamination risks, while allogeneic therapies necessitate infrastructure that enables efficient, scalable processing and segregation of donor materials.
As such, ATMP developers and manufacturers are under increasing pressure to ensure their cleanroom facilities meet these complex needs.
The benefits of modular cleanrooms
As the ATMP field advances, the demand for specialised cleanroom facilities is rising. Traditional stick-built cleanrooms, while functional, present drawbacks in the fast-paced ATMP landscape. Their construction is time-consuming, requiring extensive on-site labor and coordination of various trades, leading to potential delays, cost overruns and disruptions to operations.
Modular cleanrooms offer a solution. Unlike stick-built construction, they use prefabricated components manufactured in a controlled environment and assembled on-site, addressing the need for speed and efficiency in ATMP development and manufacturing.
As the ATMP field advances, the demand for specialised cleanroom facilities is rising
There are four key reasons why pharmaceutical companies should explore modular cleanrooms to overcome ATMP challenges:
Rapid construction and deployment: Modular cleanrooms can be built quickly and efficiently, minimising the delays and complexities associated with traditional construction methods, and potentially accelerating time-to-market for life-changing new ATMPs. By providing a single-source solution, modular construction allows ATMP developers to focus on their core competencies while ensuring efficient facility delivery.
Adaptable designs to meet unique ATMP needs and future requirements: The modular approach accommodates various layouts and configurations, addressing the diverse settings of ATMP development, from research labs to manufacturing facilities. Modular cleanrooms also allow for efficient reconfiguration and expansion as processes evolve, ensuring future-proofing in the dynamic ATMP landscape.
Modular cleanrooms allow for efficient reconfiguration and expansion as processes evolve
Streamlined regulatory compliance: Modular cleanrooms are designed to meet and even exceed stringent regulatory requirements. They promote standardisation and consistency across facilities, which is particularly beneficial for organisations with multiple locations or those collaborating with partners. This standardisation also contributes to greater efficiency, reduced risk and improved product quality.
Optimised operational efficiency: Modular cleanrooms offer significant cost advantages and operational benefits, contributing to the long-term financial sustainability of ATMP development and manufacturing. By streamlining construction and minimising on-site complexities, modular cleanrooms reduce operational risks and contribute to improved commercial viability and scalability.
Design partners forATMP and modular cleanroom experience
In the world of controlled environments, partnering with a cleanroom expert specialising in modular design - and particularly for ATMP projects - is paramount to success.
Partners with years of experience supporting ATMP projects are well-positioned to design a modular cleanroom to meet the specific needs of these complex projects.
This means not only providing a facility capable of meeting stringent sterile integrity requirements but also the equipment, capacity, and space needed to carry out the complex processes integral to ATMP manufacturing.
Modular cleanrooms can be built quickly and efficiently
An experienced partner will also be better placed to support the build of the new cleanroom, minimising the risk of delays that could impact time-to-market for new ATMP products.
AES, for instance, has decades of experience in delivering effective modular cleanrooms for clients across the pharmaceutical space, and our team also has a strong track record supporting ATMP innovators with their unique cleanroom needs.
We can offer comprehensive support throughout the entire process, from initial design and engineering to fabrication, installation and validation - all of this can streamline project delivery, minimising costly downtime and delays. Additionally, we can advise on future expansion or reconfiguration needs, adapting your cleanroom as your business evolves.
ATMP project success
As the ATMP industry continues to grow, modular cleanrooms can offer the infrastructure and flexibility needed to bring these transformative therapies to market.
Choosing a partner like AES with a proven track record in modular cleanroom design for ATMPs ultimately mitigates risk and maximises return on investment.
Their understanding of industry best practices and cutting-edge technology ensures a high-quality, compliant cleanroom tailored to an ATMP project’s specific requirements. This collaboration leads to improved operational efficiency, reduced maintenance costs, and enhanced product integrity, giving you a competitive edge in your market.
