Cell and gene therapies offer hope to patients suffering from chronic diseases. Credit: Have a nice day Photo via Shutterstock.

Deploying robots in pharmaceutical manufacturing will lead to enhancements beyond productivity increases, resulting in better compliance, operational excellence and the enabling of large-scale development of therapeutic products needed for emerging treatments such as cell and gene therapy.

Cell and gene therapies offer hope to patients suffering from chronic diseases and can replace lifelong treatments. For example, bluebird bio’s gene-modified cell therapy, Zynteglo, is a one-time treatment for patients with beta-thalassemia, replacing a lifetime of regular blood transfusions. However, the manufacturing process required for drugs such as Zynteglo is a key barrier to further development and wider patient access to emerging cell and gene therapies.

Cell and gene manufacture is highly complex

Consistent manufacturing of cell and gene therapies, at speed and with limited costs, is difficult given their inherent variability as biological products and the need to personalise them to the patient. For example, in autologous gene-modified cell therapy, cells must be taken from each individual, cryopreserved and transported to a highly specialised good manufacturing practice (GMP) facility, where they are then genetically edited and the cell therapy is manufactured. The treatment must then be transported back to the patient to be administered, all in an efficient and timely manner. Drug manufacturers require incredibly tight logistics which follow all regulated quality conditions.

In regions such as Europe, manufacturing capabilities are not yet at the level that would be required with larger-scale approval and adoption of cell and gene therapies.

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Manufacturers look to Industry 4.0 technologies

The pharmaceutical industry is investing in technologies such as robotics to help to scale, speed and improve quality control in cell and gene therapy manufacturing. In 2021, Takeda invested $126 million in a robotics-enabled cell therapy manufacturing factory in California, while in 2023, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) revealed it was trialling a stem cell-manufacturing robot, the CellQualia.

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Multiply Labs is leading the adoption of robotics in cell and gene therapy manufacture through the establishment of a consortium. Multiply Labs, Cytiva, Thermo Fisher Scientific, Charles River Laboratories and the University of California San Francisco (UCSF) are collaborating to automate the manufacturing of gene-modified cell therapies with a GMP [good manufacturing practice]-compliant robotic manufacturing system at an industrial scale.

The five members are working together in collaboration to create one product. Multiply Labs provides expertise in cloud robotics, with products in its portfolio including robots for capsule manufacturing, capable of producing 30,000 drug capsules per day, and its QCmaestro automation software. Cytiva is automating a bioreactor for cell therapy manufacture, used in the production of market-approved chimeric antigen receptor T cell therapies.

Thermo Fisher Scientific is automating incubator technology, with the Heracell VIOS incubator able to control COâ‚‚  levels, humidity and airflow. Charles River is automating quality control testing, with its Celsis Rapid Microbial Detection and Endosafe Endotoxin Testing platforms used for testing cell therapy products, reducing the final release testing of cell therapies from 14 days to three.

Finally, UCSF is overseeing the manufacturing process through a sponsored research agreement. The finished robotic system will reduce manufacturing bottlenecks and minimise human contamination, while also being adaptable and having a very high throughput. Thermo Fisher Scientific will provide its robotic Heracell VIOS incubators, which can control carbon dioxide levels, humidity, and airflow, making them ideal for cell therapy manufacturing. Partnering with Multiply Labs, Thermo Fisher aims to automate incubation and gene delivery processes with cloud robotics.

According to GlobalData’s sales and forecast database, the cell and gene therapy market is set to surpass $81 billion by 2029. The consortium’s finalised robotic system could become the solution to cell and gene therapy manufacturing issues, and help to increase the affordability and accessibility of these medicines.