The pharmaceutical industry has witnessed significant advancements in recent years, particularly in the realm of advanced manufacturing technologies (AMTs). These innovations aim to enhance drug quality, efficiency, and customization. Despite their potential, the adoption of AMTs in generic drug manufacturing has been slow, mainly due to high upfront investment costs and regulatory barriers.
Table of Contents
Continuous Manufacturing
Continuous manufacturing is a key AMT that has gained significant traction in the pharmaceutical sector. This method streamlines production, reduces waste, and enhances quality control. It also allows for quicker response to market demands and reduces the need for extensive warehouse storage. Companies such as Pfizer, Eli Lilly, and GSK have successfully implemented continuous manufacturing, resulting in the approval of several medicines created using this method in the US.
3D Printing
3D printing technology has made significant inroads in the pharmaceutical sector. It is used for personalized drug formulations, medical device manufacturing, and drug delivery systems. By enabling the production of complex drug structures with precision, 3D printing has the potential to revolutionize drug manufacturing and customization. Aprecia Pharmaceuticals pioneered the first FDA-approved 3D-printed medication, SPRITAM, designed for rapid dissolution in water, facilitating ingestion for patients with swallowing difficulties.
Gene and Cell Therapy Manufacturing
The gene and cell therapies field presents manufacturing challenges and opportunities distinct from traditional pharmaceuticals. These therapies often involve highly specialized processes, such as modifying and manipulating a patient’s cells to create personalized treatments. To meet the increasing demand and ensure the success of these therapies, the biopharma industry is turning to innovative manufacturing technologies. For instance, Yescarta, a CAR-T cell therapy, involves genetically modifying a patient’s T cells to target and destroy cancer cells. Gilead’s expansion of its Amsterdam facility to produce Yescarta for 4,000 patients annually exemplifies the crucial role of advanced manufacturing infrastructure in efficiently delivering these cutting-edge therapies to patients.
Robotic Process Automation (RPA)
Robotic process automation has been integrated into drug manufacturing to enhance speed and precision in various aspects of the production process. Robots are utilized for tasks like dispensing, labeling, and packaging, reducing the potential for human error and increasing production efficiency. Eli Lilly and Company and Strateos, Inc. introduced the Lilly Life Sciences Studio lab in San Diego, a state-of-the-art robotic laboratory designed to accelerate drug discovery.
Blockchain for Supply Chain Transparency
Ensuring the authenticity and integrity of pharmaceutical products throughout the supply chain is a critical concern. Blockchain technology has emerged as a solution to enhance transparency, traceability, and security in the pharmaceutical supply chain. IBM, KPMG, Merck, and Walmart teamed up for an FDA pilot program that aims to use blockchain to enhance the traceability and security of prescription drugs in the US.
Virtual Reality (VR) and Augmented Reality (AR)
VR and AR technologies are entering pharmaceutical manufacturing for training, design, and quality control. These immersive technologies provide a more interactive and intuitive approach to complex tasks. GSK has incorporated VR and AR into its pharmaceutical manufacturing facilities for training. Employees can undergo virtual training exercises, improving their skills and efficiency in a controlled, immersive environment.
Addressing Barriers to Adoption
Despite the potential benefits of AMTs, their adoption in generic drug manufacturing faces significant barriers. The cost of implementing these technologies often outweighs the return on investment that generic manufacturers might expect relative to other options. Additionally, the fast turnover, large portfolio nature of generic drug manufacturing makes it challenging to adopt AMTs, particularly continuous manufacturing.
To address these barriers, it is essential to develop a platform approach and better document the return on investment. This would help drive adoption of AMT technologies among mainstream generic manufacturers. Furthermore, regulatory constraints and uncertainty need to be addressed. The FDA’s work-in-progress nature of regulations regarding the use of AMTs, with guidances and pilots in the works, must be complemented by efforts to address the nature of the generics business, with a large installed base of products and questions about how to address technology adoption for product portfolios, not just individual products.
Conclusion
Innovative manufacturing technologies hold significant potential to enhance the quality and efficiency of generic drug production. However, their adoption faces significant barriers, including high upfront investment costs and regulatory uncertainty. To overcome these challenges, it is crucial to develop a platform approach, better document the return on investment, and address regulatory constraints. By doing so, the pharmaceutical industry can harness the full potential of AMTs to improve the resilience of generic drug supply chains.
“AMTs, continuous manufacturing in particular, do not align with the fast turnover, large portfolio nature of generic drug manufacturing.” – Brookings Institution
References
- Duke University. (2024). Considerations for FDA’s New Advanced Pharmaceutical Manufacturing Programs. Retrieved from https://healthpolicy.duke.edu/publications/considerations-fdas-new-advanced-pharmaceutical-manufacturing-programs
- Brookings Institution. (2024). Workshop Summary: Technology Solutions for Improving the Resilience of Generic Prescription Drug Manufacturing. Retrieved from https://www.brookings.edu/articles/workshop-summary-technology-solutions-for-improving-the-resilience-of-generic-prescription-drug-manufacturing/
- National Academies of Sciences, Engineering, and Medicine. (n.d.). Identifying Innovative Technologies to Advance Pharmaceutical Manufacturing. Retrieved from https://www.nationalacademies.org/our-work/identifying-innovative-technologies-to-advance-pharmaceutical-manufacturing
- National Center for Biotechnology Information. (n.d.). Innovations in Manufacturing Drug Products. Retrieved from https://www.ncbi.nlm.nih.gov/books/NBK570316/
- Pharma News Intel. (2023). Innovative Tech for Drug Manufacturing: Revolutionizing Pharma. Retrieved from https://pharmanewsintel.com/features/innovative-tech-for-drug-manufacturing-revolutionizing-pharma
