Next-Generation Therapiescross the Human-AI boundary, enabled by Bioprocess 5.0 for larger production scales
Bioprocess 5.0, the latest evolution in the biomanufacturing industry, is integrating advanced digital technologies, automation, and sustainability principles to revolutionise the way complex biomolecules are produced.
One of the most significant aspects of Bioprocess 5.0 is its focus on sustainability. Renewable energy is being hailed as one of the most impactful movements to decrease the footprint of bioprocessing production. Companies like MilliporeSigma, a life science business, are leading the charge, currently operating with 78% renewable electricity and aiming to increase that value to over 90% in Q1 of 2026.
Successful bioprocessing pipelines in Bioprocess 5.0 are also focusing on connecting upstream and downstream efforts for improved yield, robustness, and reproducibility. This connection is evident in the manufacturing of CAR T therapies, which are moving towards autoimmune diseases with larger patient populations. The need for autonomous systems in Bioprocess 5.0 is highlighted by CAR T manufacturing for autologous cancer cell therapy.
Partnerships are playing a crucial role in the implementation of Bioprocess 5.0. Cytiva, for instance, has announced a partnership with Cellular Origins to combine their manufacturing technologies with Cellular Origins' robotic platform, enabling the production of cell and gene therapies for larger populations. Similarly, a partnership between Millipore Sigma and Simtra Biopharma Solutions has advanced the manufacturing of ADCs, offering turnkey services for biopharmaceutical companies.
The development and evolution of complex biomolecules, such as ADC-based drugs, are having a significant impact on the bioprocessing industry. Enhertu, an ADC-based blockbuster drug, achieved global sales exceeding $1.6 billion in 2022. The complexity of these biomolecules requires additional regulatory and manufacturing considerations.
Digital tools are a key component of Bioprocess 5.0, with human-centric automation being a hallmark of the new era. These digital tools are designed to work with humans to enhance manufacturing capabilities. Digital twins, virtual replicas that simulate processes, are used in Bioprocess 5.0 to test scenarios and increase process consistency.
The use of artificial intelligence (AI) for real-time optimization and control of bioprocess parameters is another hallmark of Bioprocess 5.0. Peter Marks, the former director of the Center for Biologics Evaluation and Research (CBER) at the FDA, has urged regulatory approaches that leverage repeated information while allowing for customisation to transform N-of-1 therapy into N-of-many therapies.
The recent story of Baby KJ, who received a bespoke gene editing therapy to treat his severe metabolic disorder, has added new hope for scaling personalised therapies. Despite the complexity of these therapies, the therapy for Baby KJ was not as expensive as one might think, due to the fast timelines to address his urgent health status.
However, the true impact of Bioprocess 5.0 will kick in when there is a clear definition of the value proposition for humans and people's roles evolve. As Mostafa, a key actor in the biomanufacturing industry, emphasises, Bioprocess 5.0 is not focused on local optima but aims at broader solutions, improving sustainability metrics, overall human experience, and defining the value proposition for humans.
The development of N-of-1 therapy, as discussed in an editorial published in The New England Journal of Medicine by Peter Marks, is another area where Bioprocess 5.0 could have a significant impact. Marks urges regulatory approaches that leverage repeated information while allowing for customisation to transform N-of-1 therapy into N-of-many therapies.
In conclusion, Bioprocess 5.0 is set to redefine the biomanufacturing industry, offering a more sustainable, efficient, and personalised approach to the production of complex biomolecules. As the industry continues to evolve, we can expect to see more partnerships, advancements in digital tools, and a focus on human-centric automation.
