The promise and challenges of Antibody-Drug Conjugates: CPHI North America insights – part 2

In the first part of our blog, we explored developments in the Antibody-Drug Conjugate (ADC) space. We took a deep dive into highlights from a presentation by Dr. Kishore Hotha, Veranova‘s Global Vice President of AR&D Operations, at CPHI North America. 

We reviewed the challenges encountered in ADC development and manufacturing, and build on this in this second part of the conversation, where we’re focusing on ways to address these challenges effectively.

Overcoming challenges in ADC development

Advances in chemical stability and conjugation chemistry have significantly improved the analytical strategy for ADCs. Determining critical quality attributes for analytical tests is key in ADC linker development. Companies must have a robust analytical approach in place, incorporating a defined regulatory procedure, state-of-the-art equipment, and strong technical expertise.

As discussed, one of the critical steps in overcoming the challenges of ADC development is establishing a collaborative and transparent partnership with a CDMO. A reliable CDMO can provide expertise in ADC linker manufacturing, analytical development, and formulation. They can also offer support in navigating regulatory requirements and ensuring compliance throughout the development and manufacturing process. Moreover, partnering with a CDMO with deep technical expertise can provide invaluable insights, especially in rapid scale-up, method development, and comprehensive process characterization.

Building and maintaining close relationships with suppliers, contract manufacturers, and other stakeholders is crucial for navigating the complexities of the ADC supply chain. Open communication and collaboration can help identify and address potential risks before they escalate, and enable quick responses to unforeseen disruptions, ensuring continuity of supply. Strong partnerships across the supply chain are instrumental in upholding consistent quality and reliability throughout the entire ADC development and manufacturing process. Moreover, these collaborative relationships foster a vibrant exchange of knowledge and expertise, empowering partners to address supply chain challenges with innovative solutions and continually optimize ADC production.

To achieve supply chain excellence in ADC development and manufacturing, pharmaceutical companies should adopt several strategies:

Diversification of suppliers: Reducing reliance on a single source for critical materials can mitigate the impact of disruptions. Implications from the latest regulations and policies around the world, like the Inflation Reduction Act (IRA) in the US, need to be carefully assessed.

Strategic inventory management: Maintaining adequate safety stocks of critical materials can provide a buffer against supply chain disruptions.

Robust risk management plans: Developing and implementing contingency plans to address potential risks can help ensure business continuity.

Technology adoption: Leveraging advanced technologies like blockchain for traceability and real-time visibility can enhance supply chain transparency and efficiency.

The development, manufacturing, and supply chain management of ADCs are complex and multi-faceted processes.

While the complexities can be daunting, they also present opportunities for innovation and improvement. 

By understanding the challenges, building strong relationships, and adopting proactive strategies, pharmaceutical companies can navigate the complexities and achieve supply chain excellence, ultimately benefiting patients worldwide.