Personalized Therapy: Revolutionizing biopharma production and application

Breaking ground in biopharma: From one-size-fits-all to personalized care

The biopharmaceutical manufacturing landscape is undergoing a profound transformation, driven by the rise of personalized therapies, particularly in Cell and Gene Therapeutics. This revolutionary shift is not only redefining the products being developed but also necessitating a complete overhaul of production tools and processes. As we delve into this cutting-edge field, we'll explore the unique challenges and groundbreaking innovations propelling the industry into uncharted territory, promising tailored treatments that could dramatically improve patient outcomes and reshape healthcare's future.

The rise of personalized therapies

Personalized therapies are spearheading this revolution, often tailored to individual patients and requiring a fundamental rethinking of production methods. Cell-based therapies, such as those utilizing stem cells, have demonstrated remarkable potential in treating a wide range of conditions, from genetic disorders to degenerative diseases (1). A notable example is Zolgensma®, an AAV9-based gene therapy for spinal muscular atrophy (SMA). This groundbreaking treatment, FDA-approved in May 2019, relies on an adherent cell culture (2). Zolgensma's success demonstrates that adherent-based processes can be effectively scaled for commercial production, challenging the notion that suspension cultures are always necessary for large-scale manufacturing.

Challenges and innovations in production

The success of therapies like Zolgensma® underscores the potential of adherent-based systems, but it also reveals significant challenges in production and scaling. High costs, upscaling difficulties, and ensuring reproducibility are among the hurdles manufacturers face (3). Transitioning from laboratory-scale production to commercial manufacturing while maintaining product quality is a complex task. Moreover, traditional adherent cell culture systems, such as multi-trays, are often space-intensive and labor-intensive when scaling up.

To address these challenges, the industry is developing innovative tools and processes. Novel bioreactor technologies are emerging as game-changers in adherent cell culture. These systems offer several advantages, including increased productivity in a smaller footprint, reduced labor requirements, and improved scalability compared to traditional multi-tray systems. Companies like Green Elephant Biotech are pioneering sustainable solutions for adherent cell cultivation. Their CellScrew® product offers a large growth area in a compact design, reduces manual labor requirements, and is manufactured from plant-based materials, aligning with sustainability goals.

Sustainability and economic considerations

As the biopharma industry evolves, there's a growing emphasis on sustainability, particularly in production processes. This focus is driving innovations in sustainable materials, waste reduction, and energy efficiency. The development of culture vessels and labware from plant-based plastics reduces reliance on petroleum-based products. Compact bioreactor systems that require less energy for operation and environmental control are also becoming more prevalent.

The economics of personalized therapy production are complex. While adherent systems like multi-trays are still viable for clinical-scale production, they become less cost-effective at larger scales. Suspension-based systems in single-use bioreactors also provide cost benefits but may face challenges in transfection efficiency.

A new era of biomanufacturing

The field of personalized therapy is driving a revolution in biopharmaceutical manufacturing. Companies like Green Elephant Biotech are leading the charge towards more sustainable and efficient production methods. Their CellScrew® system exemplifies this approach, offering a large growth area for adherent cells in a compact, sustainable format.

As we look to the future, the integration of sustainable practices in daily life and research will be crucial. Researchers and industry professionals should consider incorporating technologies like CellScrew® and other plant-based labware into their workflows, contributing to a more sustainable and efficient biopharmaceutical industry.

The journey towards fully realized personalized therapies is ongoing, but with continued innovation in production methods and a commitment to sustainability, the promise of these life-changing treatments is closer than ever to becoming a widespread reality (4).

References

(1) Bracewell, D. (June 16 2020). Personalized Meds Will Drive Sector-Wide Bioprocessing Innovation. Genetic Engineering & Biotechnology News available from https://www.genengnews.com/topics/bioprocessing/personalized-meds-will-drive-sector-wide-bioprocessing-innovation/

(2) Baghirzade R, Adherent versus suspension based platforms - what is the near future of viral vector manufacturing?, Cell & Gene Therapy Insights 2021, DOI 10.18609/cgti.2021.180, available from https://www.insights.bio/cell-and-gene-therapy-insights/journal/article/2244/Adherent-versus-suspension-based-platforms-what-is-the-near-future-of-viral-vector-manufacturing

(3) Chatel A, Drugmand JC, Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines, BioPharm International (September 3, 2020), available from https://www.biopharminternational.com/view/commercial-production-of-gene-therapies-using-suspension-or-adherent-cell-lines4

(4) Branke J, Farid SS, Shah N, Industry 4.0: a vision for personalized medicine supply chains?, Cell Gene Therapy Insights 2016;2(2), 263-270, July 6 2016, 10.18609/cgti.2016.027