Five Key Trends In CMC

By Matthew Cotten, Senior Manager in Regulatory Affairs, PharmaLex

CMC (Chemistry, Manufacturing, and Controls) is evolving in response to technological advancements, regulatory shifts, and industry challenges. Digitalization is transforming CMC through AI, automation, and cloud-based platforms, improving efficiency, compliance, and decision-making. Real-Time Release Testing (RTRT) is also gaining traction to enhance quality assurance.

Sustainability is another major focus, with regulators emphasizing green manufacturing and environmental compliance. CMC plays a critical role in reducing environmental impact by optimizing supply chains, improving energy efficiency, and implementing eco-friendly materials. Pharmaceutical companies are expected to align with national health systems' sustainability targets, such as the UK’s NHS net-zero commitment.

Building resilient supply chains remains crucial, particularly after recent global disruptions. Regulatory bodies, such as the EMA, are increasing oversight to prevent medicine shortages. Companies must integrate CMC-driven risk mitigation strategies to enhance supply chain security.

CMC is also instrumental in post-merger operations, ensuring regulatory compliance and manufacturing harmonization. CMC experts are now involved in M&A due diligence to assess product portfolios, regulatory risks, and integration challenges.

Personalized medicine and small-batch manufacturing present new regulatory and quality challenges due to short product shelf lives. CMC must be embedded early in development to address compliance complexities and supply chain demands.

As the industry adapts to these trends, a flexible and innovative CMC approach will be essential. CMC professionals will be key to maintaining compliance, optimizing processes, and driving pharmaceutical progress in a rapidly changing landscape.