Next-Gen Therapies Bridge the Human-AI Gap in Bioprocess 5.0 for Expansion
In the realm of biomanufacturing, a new era is upon us. Bioprocess 5.0, the latest generation of biomanufacturing, is integrating advanced digital technologies, automation, and sustainability principles to revolutionise the industry.
The global biomanufacturing landscape has seen significant changes, particularly with the emergence of complex biomolecules like antibody drug conjugates (ADCs). These require additional regulatory and manufacturing considerations, as highlighted by the complexity of Baby KJ's bespoke gene editing therapy for his severe metabolic disorder. Despite the challenges, the therapy's costs were surprisingly lower than expected due to the fast timelines required to address his urgent health status.
Peter Marks, MD, PhD, former director of the Center for Biologics Evaluation and Regulation (CBER) at the FDA, believes that regulatory approaches should leverage repeated information from product to product while allowing for necessary customization. This philosophy is echoed in Bioprocess 5.0, where data is leveraged at every stage for faster decisions and fewer batch failures.
Artificial Intelligence (AI) tools are a key component of Bioprocess 5.0, optimising and controlling bioprocess parameters in real-time. Digital twins, virtual replicas of processes, are used to test scenarios and increase process consistency. One example process in Bioprocess 5.0 is particle characterization, bridging the balance between human decision-making and digital tools.
Sustainability is a significant focus of Bioprocess 5.0. Companies like Millipore Sigma and AstraZeneca are aiming to increase their use of renewable energy and reduce greenhouse gas emissions. MilliporeSigma currently operates with 78% renewable electricity and aims to increase this value to over 90% in Q1 of 2026. AstraZeneca aims to increase the share of renewable energy it uses to 100% and reduce greenhouse gas emissions by 98% by 2026.
The partnership between Millipore Sigma and Simtra Biopharma Solutions creates a turnkey offering for biopharmaceutical companies seeking ADC and bioconjugation, linker/payload manufacturing, drug product formulation development, and fill-finish capabilities. This collaboration underscores the industry's shift towards connected bioprocessing pipelines, focusing on connecting upstream and downstream efforts for improved yield, robustness, and reproducibility.
CAR T manufacturing for autologous cancer cell therapy is seen as a prime example of the need for autonomous systems in Bioprocess 5.0. Benjamin Hein, head of life science services at Millipore Sigma, stated that connecting the bioconjugation and fill-finish steps will be a value-add for clients, meeting their ambitious timelines and allowing the broadest number of patients to benefit in the fastest and safest possible way.
The recent story of Baby KJ has added new hope for scaling personalized therapies. According to Kiran Musunuru, MD, PhD, one of the lead physicians overseeing KJ's case, the therapy's cost was "not as expensive as you might think." For Bioprocess 5.0 to truly kick in, there needs to be a clear definition of the value proposition for humans and an improvement in sustainability metrics and overall human experience, as emphasised by Mostafa.
Bioprocess 5.0 also incorporates human-centric automation, with digital tools designed to work with humans to enhance manufacturing capabilities. As we move forward, it is clear that Bioprocess 5.0 will play a crucial role in advancing the biopharmaceutical industry, driving innovation, and improving patient outcomes.
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