The biomanufacturing technology provider and the Irish facility said that the rapid growth of cell and gene therapies (CGTs) together with the complexities of the manufacturing process has resulted in an urgent shortage for highly skilled CGT manufacturing staff.
NIBRT will employ the fully operational scale-x carbo bioreactor for dedicated cell culture and viral manufacturing training courses for academia and industry experts from the third quarter of 2021.
The intensified bioreactor will play a key role in helping to upskill newcomer to expert level biopharma professionals and researchers and eventually leveraging such scalable technologies to bridge the clinical gap, said the partners.
In terms of the trigger for the tie-up, Marie Jourdan, vice president, marketing and product management, Univercells, said the company was attracted by NIBRT’s “innovative and holistic” approach to trainees from both industry and academia. “And we thought that our intensified and continuous platforms for viral manufacture would be a good fit.”
The scale-X carbo system is suitable for both lab-scale process optimization and clinical to even commercial-stage GMP manufacturing due to the functionalities and scales it offers, she said.
“The system is well-suited to optimize key process parameters during the development stage, offering close monitoring capabilities such as fixed-bed sampling for direct biomass analysis. At the same it provides the reproducibility and reliability required for GMP conditions thanks to its homogeneous structured fixed-bed bioreactor and its automated process control and monitoring.
“The intermediate scale bioreactors offer 10 and 30m² available for growth, which for some applications can be sufficient to deliver Clinical Trial Material (CTM) and even commercial-scale product for low-dosage applications.
“A recent application on Rubella vaccine demonstrated that the scale-X carbo system can yield upwards of 50m doses per year, which can successfully be used to fill the supply gap needed to meet vaccination targets.”
Digitalization, industry 4.0
In terms of what more can be done to address the growing skills gap in the advanced therapy medicinal products (ATMPs) sector, John Milne, training director, NIBRT, told us that, over the next decade, as the industry moves to new paradigms in manufacturing aligned with industry 4.0 initiatives, the need to develop personnel competent in data management and the use of more automated technologies will be more important. “This will be particularly relevant within the manufacture of CGTs.”
Training for GMP manufacturing is best achieved using competency-based training solutions that encourage the trainee to develop critical learning skills in an environment that uses equipment and processes that are aligned to real life scenarios, he added.
Jourdan said key to plugging the CGT manufacturing skills gap is raising awareness about it.
Apart from the main development and manufacturing experts, a whole range of support expertise must be considered from analytical sciences, to quality and validation, maintenance and troubleshooting specialists, she said.
Each actor in the chain, said Jourdan, needs to get up to speed on the latest technological developments to ensure smooth and optimal operations; they also must grasp the role that digitalization and automation – industry 4.0 – will increasingly play.
“Industry players are progressively acknowledging the need for action and taking ownership of their training strategy to continuously upskill their workforce. They can team up with centers of expertise such as NIBRT to design and deliver on-the-job courses, practical training in pilot plant environment, or more conventional classroom and online education programs.
“Unfortunately, more conventional university education programs are often lagging behind, taking longer to integrate the latest developments of the sector in terms of therapeutic modalities and production technologies. The academic students and researchers of today are the industrial experts of tomorrow, it is of paramount importance to keep investing in them. Biopharma companies can contribute to expanding university programs by offering workshops and other exercises to start disseminating know-how at the earliest stage.
“At Univercells Technologies, we strive to develop versatile technology platforms that will be easy to adopt and flexible to accommodate numerous process requirements. This will contribute to develop a strong core of skillsets to be transferable to a range of applications.”