Manufacturing challenges for cell and gene therapies

The cell and gene therapy industry is presented with a significant challenge in terms of facility design, as traditional “one process fits all” facility designs do not meet the needs of both cell and gene therapy developers.

Cell therapies fall into two broad categories, where administered cells are either derived from the individual patient (autologous) or from a donor (allogenic). The manufacturing process to generate cell therapies occurs ex vivo. In its simplest form, a manufacturing process may consist of a short expansion regime prior to formulation and administration. Alternatively, the processes can be lengthy and complex, requiring cycles of expansion, stimulation, treatment with external growth or differentiation factors, or indeed genetic manipulation with viral or non-viral systems in order to reprogram the cells.

For gene therapies the manufacturing process occurs ex vivo with the purpose of generating a functional product that can alter or target cell function. The manufacturing processes for gene therapies is typically more aligned with cell-based viral vaccine production methods.

Traditional pharmaceutical or biologic products have tended towards a common manufacturing process or platform, which can be used to manufacture a variety of different products to treat a broad number of clinical indications. The huge variety observed in cell and gene therapy products translates to the plethora of manufacturing processes trialled, with a diverse range of technologies and scales being explored and developed. This is expected to put a significant strain on current GMP manufacturing infrastructure as not all facilities can accommodate the range of processes.

Snapshot of industry in 2016:

There is
>4300m2total clean room footprint



Whilst the number of GMP cell and gene therapy manufacturing facilities in the UK continues to increase (view GMP manufacturing survey here), there is minimal spare capacity and the demand for cell and gene therapy manufacturing space presents the risk of demand exceeding available capacity. The construction of the Cell and Gene Therapy Catapult manufacturing centre will help meet this demand and mitigate this risk.

The centre has been specifically designed to meet the demands of cell and gene therapy manufacturing. The adaptable clean room design will allow companies to manufacture their own products, facilitating autologous or allogenic cell and gene therapies, as well as viral vector processes. The centre aims to meet the potential needs of many different customers, who may each have very different manufacturing processes.

Architecturally segregated modules will give manufacturers control of their manufacturing strategy.

The centre is also forward looking in design. Cell and gene therapy manufacturing is in its infancy and it is likely that as it matures, manufacturing processes will evolve and change. The centre is designed to accommodate up to 1000 litre single use bioreactors or multiple automated autologous process for processes of the future, in addition to meeting the current demands of the industry. As cell and gene therapy manufactures grow, the centre will further facilitate their expansion due to its repeatable design.

A support network of technology and service companies plus an established logistical supply route will also help ensure that companies utilising the centre can accelerate their programmes and establish both clinical and commercial manufacture from a single site.

Take a virtual tour of the centre here: