Five key trends in CMC

Companies are increasingly leveraging AI or automation tools to streamline regulatory documentation through digitalization of data, which paves the way to improving speed and accuracy and, in the longer term, driving cost savings.¹ 

Another key digital tool is the growth of cloud-based data platforms to support modern CMC processes by allowing real-time data storage with security and quality tracking. Structured content and data management solutions are paving the way for a more seamless data exchange platform to support CMC submissions.¹ AI, machine learning, and big data analysis are other tools that could create predictive modeling and algorithms. This allows companies to accelerate decisions, avoid issues, optimize processes, and improve quality.² Increasingly, regulatory authorities are offering guidance to support companies with the use of AI in their regulated processes.^3,4 

Digital innovations such as AI are also expected to gain prominence using Quality by Design principles for new medicines.⁵ 

Additionally, newer methods such as Real Time Release Testing (RTRT) are predicted to improve quality assurance.⁶ The ICH and the European Medicines Agency (EMA) have defined RTRT as “the ability to evaluate and ensure the quality of the in-process and/or final product based on process data, which typically include a valid combination of measured material attributes and process controls (ICH Q8).”⁷

Regulators are expected to place a heightened focus on green manufacturing and environmental compliance. 

For example, merging entities are increasingly expected to be evaluated not just on product quality but also on their environmental footprint and compliance with evolving green standards. CMC functions can support these objectives by embedding sustainability and green chemistry in pharmaceutical development processes.⁸ That includes using components with low toxicity, that are more eco-friendly, and that do not require special precautions for handling. 

An important step for CMC functions is to evaluate supply chains for sustainability practices, including energy efficiency and waste management.⁹ An increasingly important area of focus will be medicine packaging and recycling, balancing the importance of patient safety with effective ways to reduce the carbon footprint.¹⁰ 

Designing energy-efficient processes would also allow companies to meet regulatory emissions targets set by national health systems and to reduce operational costs. By way of example, the U.K.’s National Health Service is committed to a net zero target for its operations and supply chain by 2045, which will depend on suppliers, including pharmaceutical companies, supporting those objectives.¹¹

Disruptions to manufacturing sites for many different reasons have underscored the importance of resilient and robust supply chains.¹² 

COVID-19 demonstrated the problems with relying on a few markets to supply essential medicine materials, which has prompted regulatory authorities to act to protect the supply chain. In Europe, the EMA’s Medicines Shortages Steering Group (MSSG) has established recommendations to address supply chain vulnerabilities for critical medicines.¹³ 

Managing global suppliers adds complexity to maintaining compliance across sites and countries. CMC must ensure product quality and regulatory compliance of the supply chain. Pharmaceutical manufacturers must also act to prevent supply chain disruption and product shortages. 

An increasing focus in the future will be to integrate supply chain mitigation and product security through a dedicated regulatory and CMC-focused role to manage complex global supply chains and address the questions likely to come from bodies such as the MSSG and the EMA’s Medicine Shortages Single Point of Contact (SPOC) Working Party, which monitors and reports events that could affect the supply of medicines in the EU.¹⁴ 

The trend toward personalized medicine and small batch manufacturing creates additional complications for CMC since these products typically have a short shelf life. This creates regulatory complexities, challenging quality assurance and control standards, for example, real-time release. 

This will require very careful management of the supply chain, which puts the onus on companies producing these products to have, or turn to, CMC experts in personalized medicine. Importantly, CMC should be embedded as part of the development strategy.¹⁷ Inevitably, these CMC processes and the oversight involved will contribute to cost increases.

As the CMC landscape continues to evolve, industry focus will increasingly turn toward how to respond to fast-moving changes. One area that companies are expected to emphasize is the integration of digital tools such as AI and cloud-based platforms to enhance efficiency and accuracy in regulatory processes. 

Building resilient supply chains will remain a critical priority, particularly in light of the disruptions experienced during past global events. At the same time, an emphasis on environmental compliance will reshape manufacturing practices. 

The role of CMC in post-merger operations will be paramount to support regulatory compliance and operational excellence during transitions. Additionally, the shift toward personalized medicine will necessitate a more sophisticated approach to manufacturing and quality assurance. 

These trends underscore the importance of a flexible and innovative CMC strategy. As the industry navigates these complexities, CMC professionals will play a crucial role in driving progress and helping to keep quality and compliance at the forefront of drug development and lifecycle management.