The global cell and gene therapy (CGT) sector is set to experience strong growth in the coming years, and is projected to reach $14 billion by 2025. A combination of factors is driving expansion including ongoing acquisition activity, significant investment in production and a growing pipeline.
With an increasing number of therapies receiving approval, the companies working in this highly specialized area of medicine must address complex and evolving operational challenges in order to keep pace with growing demand.
With production moving from small, lab-style facilities to larger operations, more CGT manufacturers are turning to a planning roadmap to address how they will scale-out. In other instances, the absence of a coherent long-term plan is posing challenges for manufacturers, and may lead to delays of up to two years as companies seek to renovate or retrofit existing space or build new facilities.
While the challenges of scaling out CGTs are multi-faceted, flexible facilities offer a path to future-proof operations.
Scale-out specifics
Challenges arise when companies focus solely on production capacity and do not look at the needs of related upstream processes that feed into manufacturing.
For example, when planning to scale out, CGT manufacturers need to consider providing greater QC lab space so staff can update and maintain multiple pieces of specialized equipment simultaneously. Companies must also consider how additional warehouse space can be deployed; that is, not only focusing on GMP activity, but also staging and kitting of single-use bags, tubing and process kits.
Manufacturers face issues in transferring knowledge and tech expertise from existing lab-style facilities to larger manufacturing sites. This is evident on two fronts: First, there is a finite number of staff with the requisite skills and expertise to manage the transfer of technology and processes. Second, CGT companies need to ensure that while transfers take place to new manufacturing sites, there are adequate people to maintain operations and production at their existing facilities.
Each piece of cell and gene therapy lab equipment is specialized and requires highly trained, skilled individuals to maintain. If a specialist is deployed as part of a scale-out operation, the company must ensure that there is an equally skilled colleague who can maintain equipment at the existing facility.
With production ramping up, manufacturers also face challenges in areas such as viral vector production, kitting, media and buffer production, and data integrity. Typically, CGT manufacturers work with one viral vector supplier, but because of greater demand, some companies in this sector may consider sourcing and working with a second supplier. This elevates concerns around sharing intellectual property with another third party in this highly specialized area and is prompting some CGT companies to look at the possibility of bringing viral vector production in-house.
Flexible solutions
Manufacturers looking to ramp up production in a seamless manner must plan for the long term and look at operational requirements that will arise during the next five to 10 years. Flexible facilities play a central role in overcoming these challenges.
For example, companies bringing viral vector production in-house will need to provide segregated QC labs as the need arises, and that capability can be enabled by the flexible facility approach. To accommodate more expansion bioreactors or incubators, facilities can be designed with large ballrooms or smaller suites with removable walls.
Similarly, flexible facilities can support CGT companies when it comes to scaling out and ramping-up production capacity. Modular structures can be deployed quickly to facilitate tech transfer, provide QC lab space and ensure staff can update and maintain multiple pieces of specialized equipment, while also providing warehouse space for GMP activity and related upstream manufacturing processes.
Looking ahead, flexible facilities will continue to play a significant role in supporting the cell and gene therapy sector’s requirements, with rapid reconfigurations and new builds underpinning growing demand.
With the CGT market predicted to experience exponential growth, flexibility will be a key driver into the future.
