From Semiconductors to Genes: Engineering Precision in Advanced Therapies
Exploring insights from ARM's JPM 2025 panel discussion and the evolving quest for molecular-level understanding in cell and gene therapy.
Background
At this year’s JPMorgan Healthcare Conference, the ARM panel discussion on "Capital Markets and Commercial Insights: Navigating Opportunities and Challenges in CGTs" brought an unexpected but interesting comparison to light. Keith Crandall of Arch Ventures, drawing from his semiconductor and photonics background, made a compelling case for how the biotech industry—specifically cell and gene therapy (CGT)—can learn from the rigor and precision that revolutionized semiconductor manufacturing.
Crandall noted that in semiconductor production, every molecule is quality-checked, and processes are controlled down to the quantum level. In contrast, CGT manufacturing still grapples with variability and a limited characterization of biological components at a molecular level. According to Crandall, the key to unlocking CGT’s full potential lies in adopting semiconductor-level precision and embedding quality control (QC) from the outset—not as an afterthought.
The Semiconductor Blueprint: A Roadmap for CGT
The semiconductor industry underwent significant transformation from its early, experimental days to become one of the most exacting fields in modern manufacturing. The drivers of this shift included:
Standardisation and Process Control: Introduction of Statistical Process Control (SPC), Six Sigma, and rigorous certification processes (Anonyuo et al., 2024).
Deep Foundational Understanding: Mastery over materials and physics that enabled predictable, repeatable outcomes.
Leadership Evolution: Semiconductor firms appointed leaders with strong manufacturing backgrounds, shifting from leaders with academic experience.
Collaborative Ecosystems: Industry-wide knowledge-sharing through consortia like SEMATECH helped accelerate improvements across the board (Irwin & Klenow, 1996).
Precision at the Molecular Level: Lessons from Semiconductors for the Future of Cell and Gene Therapy
CGT: A Field in Search of Precision
Despite the substantial advancements in CGT, significant hurdles remain, particularly in manufacturing scalability and consistency. The inherent complexity of biological systems introduces unpredictable variances—an issue that semiconductor methodologies could help address.
Key Areas for CGT Innovation Inspired by Semiconductors
Molecular-Level Understanding
Advances in single-cell analysis and multi-omics technologies are helping bridge the knowledge gap in CGT. Spain, for example, has a network of research groups conducting single-cell RNA sequencing pre- and post-CAR-T cell therapy to better understand therapeutic persistence and variability (Rodriguez-Madoz et al., 2023). Similar efforts are emerging globally, including:MIT’s Center for Biomedical Innovation (USA): Exploring process control and predictive analytics in cell therapy manufacturing.
Fraunhofer Institute (Germany): Investigating automation and in-line analytics for bio-manufacturing.
Cell and Gene Therapy Catapult (UK): Driving standardisation and scalable process development across the industry.
Standardised QC Protocols
The standardisation of QC protocols in ATMP manufacturing is evolving through the adoption of real-time process controls, automation, and the promise of harmonised regulatory frameworks from bodies like the FDA, EMA, and PMDA.Automation and Closed Systems
Leveraging automation and robotics to minimise human intervention in CGT manufacturing aligns closely with semiconductor principles. Companies such as Ori Biotech and Autolomous are pioneering efforts in digital manufacturing platforms tailored for advanced therapies.Leadership Evolution
As CGT companies advance, there is a growing recognition of the need for leadership with expertise in industrial-scale manufacturing. Bridging the gap between clinical and operational expertise could unlock significant efficiencies and scalability.
The Future Outlook: Unlocking Precision in CGT Manufacturing
Crandall’s perspective underscores that precision in biological manufacturing will do more than just improve yields and consistency—it could fundamentally change how we approach cell engineering and advanced therapeutic manufacturing. By minimising variability and embedding precision from the outset, CGT manufacturers could realise therapies that are safer, more predictable, and ultimately more accessible to patients worldwide.
Conclusion
The intersection of semiconductor precision and CGT innovation presents an exciting frontier. While biology’s inherent complexity presents challenges, adopting rigorous QC frameworks and fostering cross-industry collaboration can accelerate CGT’s trajectory from bespoke treatments to widely available, cost-effective therapies.
Lonrú Consulting continues to explore and support these transformational shifts—illuminating the opportunities for CGT companies looking to navigate complexity with precision and clarity.
References
Anonyuo, S., Kwakye, J., & Ozowe, W. (2024, November 22). A review of quality control and process optimization in high-volume semiconductor manufacturing. World Journal of Engineering and Technology Research. https://zealjournals.com/wjetr/content/review-quality-control-and-process-optimization-high-volume-semiconductor-manufacturing
Irwin, D., & Klenow, P. (1996, November 12). Sematech: Purpose and Performance. Proceedings of the National Academy of Sciences. https://www.pnas.org/doi/full/10.1073/pnas.93.23.12739
Rodriguez-Madoz, J. R., Prosper, F., & et al. (2023, November 2). Sequential Scmultiomics of In Vivo CAR-T Cells Allows Characterization of Transcriptional Differences between Patients, and Identifies IL10 As a Potential Mechanism of Resistance to CAR-T Cells in MM. Blood, 142(Supplement 1), 3433. https://ashpublications.org/blood/article/142/Supplement%201/3433/499052/Sequential-Scmultiomics-of-In-Vivo-CAR-T-Cells
