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Status and future developments for downstream processing of biological products: Perspectives from the Recovery XIX
Alois Jungbauer1, Gisela Ferreira2, Michelle Butler3
1Department of Biotechnology, Institute of Bioprocess Science and Engineering, University of Natural Resources and Life Sciences, Vienna, Austria.
Biotechnology and Bioengineering
|May 25, 2024
Summary
The rapid COVID-19 vaccine development was an extraordinary feat, not sustainable for normal drug development. Ensuring patient access to medicines globally requires balancing speed with safety and addressing complex manufacturing challenges.
Area of Science:
- Biopharmaceutical Manufacturing
- Drug Development
- Global Health
Background:
- The COVID-19 pandemic necessitated unprecedented speed in vaccine development, involving global collaboration and advanced decision models.
- This accelerated effort, while successful for vaccines, potentially sidelined other critical drug development pipelines.
- Ensuring continuous medicine supply and patient access, especially in low- and middle-income countries, remains a significant challenge.
Purpose of the Study:
- To analyze the biopharmaceutical industry's response to the pandemic and its implications for future drug development and patient access.
- To discuss the complexities and costs associated with drug manufacturing, including infrastructure and process development.
- To explore the evolution of therapeutic modalities and the adoption of new manufacturing technologies.
Main Methods:
- Review of pandemic response strategies, including communication, decision models, and global logistics for vaccine development.
- Analysis of biopharmaceutical manufacturing costs, focusing on drug discovery, process development, and infrastructure.
- Examination of emerging therapeutic formats and advanced manufacturing technologies like continuous biomanufacturing.
Main Results:
- The pandemic-driven vaccine development pace was unsustainable and came at the expense of other therapeutic areas.
- Significant complexities exist in drug manufacturing, requiring substantial investment in discovery, development, and infrastructure.
- New therapeutic modalities and advanced manufacturing technologies, such as platform processes and continuous biomanufacturing, are crucial for future efficiency.
Conclusions:
- Achieving a 10-year reduction to 1-year development time is not feasible for all drugs.
- Balancing speed, cost, safety, and global patient access is paramount for the pharmaceutical industry.
- Sustainable downstream processing and the adoption of model-based strategies are essential for the future of biopharmaceutical manufacturing.
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