By Elena Meurer
This article is part of a multi-part series on the topic of targeted medicines.
Global strategies for manufacturing targeted medicines pose unique challenges, particularly when a company is aiming for a standardized approach across different regions of the world.
The reason is that there are different regulatory frameworks across different regions, complicating companies’ efforts to standardize their manufacturing processes and ensure uniform product quality. These differences arise due to the unique socioeconomic, cultural, political, and healthcare systems in each region. With diverse formulations and personalized approaches in place, companies must, in turn, implement rigorous quality control measures to uphold product integrity.
The goal must be to ensure consistency in drug composition when possible. In certain situations, for example, a highly individualized treatment, each patient’s individual therapy may require unique formulations based on that patient’s specific needs. Such customization complicates a company’s manufacturing processes and turns meeting regulatory requirements into a formidable hurdle for manufacturers of targeted medicines.1
Points to consider
- Develop common criteria to address variability in individualized therapies, which involves definitions of standardized protocols and release criteria to ensure consistency in product quality.
- Take into consideration regional approaches to manufacturing and regulatory compliance.
- Engage regulatory expertise to navigate the complex landscape of drug approval and compliance. The engagement of regulatory consultants can help manufacturers develop strategies that align with regulatory expectations and address potential concerns.
- Collaborate across the disciplines of regulatory affairs, clinical development, and quality assurance. By taking advantage of diverse expertise, manufacturers can develop comprehensive solutions that address manufacturing, regulatory, and clinical considerations.
- Benefit from the platform approach by adjusting strategies and processes in response to emerging data, regulatory requirements, and market dynamics.
Navigating regulatory hurdles in manufacturing
Navigating the regulatory landscape, which may lack established precedents for novel therapies, requires expertise and diligence to ensure compliance with applicable guidelines.
Another significant hurdle arises when companies transition from laboratory-scale production to commercial-scale manufacture. This presents both logistical and technical challenges. Optimizing manufacturing processes for scalability while maintaining product consistency is essential for meeting demand.2
Finally, management of the supply chain for targeted medicines involves coordination of the sourcing of raw materials, production, distribution, and storage. And the specialized nature of targeted medicines could introduce complexities into the sourcing and handling of materials.
With all of this to consider, manufacturers must develop manufacturing strategies that meet the highest standards and maintain therapeutic integrity, while, at the same time, delivering maximum benefit to patients.
Get more information on the complexities involved in managing targeted medicines in our newest white paper here
