Fortifying the Flow

The fragility of global supply chains has never been more apparent. Events like the COVID-19 pandemic, geopolitical instability, and climate-related disruptions underscore the critical need for resilience, particularly within the pharmaceutical sector where interruptions can directly impact patient health. “After the Covid-19 pandemic, supply chains suffered from a lack of raw materials, excipients, packaging and high energy costs. Lead times were up to a year,” highlighted Maurizio Silvestri, executive president at DMX.

Drug shortages, often stemming from manufacturing quality issues or raw material problems, remain a significant concern. “2024 saw a record 323 drug shortages, with average durations reaching three years—nearly double the timeframe from five years ago. This trend signals a worsening market with a slower recovery. Essential medicine discontinuations have risen by 40%, creating permanent supply gaps as manufacturers exit the market,” said Laura Bray, founder of Angels for Change, a non-profit working to end drug shortages.

In response, chemical suppliers, distributors, and Chemistry, Manufacturing, and Controls (CMC) service firms in the US are implementing strategies to mitigate risks, ensure consistency, and bolster the reliability of the nation’s medicine supply.The fragility of global supply chains has never been more apparent. Events like the COVID-19 pandemic, geopolitical instability, and climate-related disruptions underscore the critical need for resilience, particularly within the pharmaceutical sector where interruptions can directly impact patient health. “After the Covid-19 pandemic, supply chains suffered from a lack of raw materials, excipients, packaging and high energy costs. Lead times were up to a year,” highlighted Maurizio Silvestri, executive president at DMX.

Drug shortages, often stemming from manufacturing quality issues or raw material problems, remain a significant concern. “2024 saw a record 323 drug shortages, with average durations reaching three years—nearly double the timeframe from five years ago. This trend signals a worsening market with a slower recovery. Essential medicine discontinuations have risen by 40%, creating permanent supply gaps as manufacturers exit the market,” said Laura Bray, founder of Angels for Change, a non-profit working to end drug shortages.

In response, chemical suppliers, distributors, and Chemistry, Manufacturing, and Controls (CMC) service firms in the US are implementing strategies to mitigate risks, ensure consistency, and bolster the reliability of the nation’s medicine supply.

Building a truly resilient supply chain requires addressing potential failure points across the entire value chain. A foundational element, and often a primary source of disruption, lies at the very beginning: the sourcing and consistency of raw materials. Issues with the quality, purity, or reliable availability of these essential inputs can cascade downstream, leading to production delays, batch failures, and ultimately, the drug shortages highlighted previously. Therefore, the proactive measures taken by chemical and material suppliers to manage inherent variability and ensure quality are fundamental to fortifying the pharmaceutical supply network.

Raw material variability represents a fundamental challenge in pharmaceutical manufacturing, especially bioprocessing. Marion Kuhn, vice president at BASF Pharma Solutions, noted: “Raw material variability has been a challenge in bioprocessing since its inception. This variability can not only impact cell performance but also alter the final composition of the drug product, leading to compliance issues and regulatory challenges.”

Inconsistencies impact yields, process efficiency, and final product quality, potentially affecting safety and efficacy. Suppliers combat this through rigorous quality control, advanced manufacturing and innovation. BASF, for instance, developed products like Kolliphor® P188 Bio and Kolliphor® P188 Cell Culture to provide consistent performance and address lot-to-lot variability in critical components. “We are employing advanced manufacturing practices and rigorous release testing protocols to ensure consistency,” said Kuhn.

Evonik addresses supply risks and sustainability by offering plant-derived alternatives. “Squalene, a lipid used as an adjuvant in parenteral drug delivery, is typically extracted from shark liver, which threatens ecosystems, increases the risk of contamination from methylmercury, varies in quality, and is prone to inconsistency in raw material supply,” said Yann d’Hervé, Head of the Health Care Business Line at Evonik.

In response, Evonik introduced PhytoSquene, avoiding variability, ecological concerns, and inconsistent supply.

Partnering with suppliers who prioritize strict raw material characterization, quality management, traceability, and global sourcing redundancy is crucial for manufacturers seeking to minimize variability.

Pharmaceutical distributors are essential nodes in the supply chain, increasingly acting as more than just intermediaries. “Customers nowadays expect distributors to be no longer just logistics and supply chain facilitators,” said Neil Houston, director of pharmaceuticals Americas at IMCD.

Now, distributors are logistics experts who enhance stability and efficiency, saving the healthcare system billions annually. Brenntag Specialties emphasizes the importance of a global footprint and market intelligence. “With boots on the ground worldwide, we spot supply chain fluctuations early and react quickly,” said John Lampariello, president of pharma North America. “This allows us to offer multiple manufacturers, giving customers flexibility and simplifying their supply chains. They remain dual-sourced without the burden of managing multiple relationships,” continued Lampariello.

Distributors play a key role in managing inventory across extensive networks, ensuring medications are available where needed while adhering to stringent storage, handling and regulatory requirements like the Drug Supply Chain Security Act (DSCSA).

CMC firms contribute significantly to supply chain reliability by ensuring robust product development and stable manufacturing processes. “CMC Pharmaceuticals focuses on creating a comprehensive CMC package from the start,” said Mike Radomsky, the president, which ensures that formulation, stability and analytical methods are aligned for scalability and regulatory compliance.

Their work extending the operational shelf-life of a military prophylactic medicine demonstrates how CMC expertise can reduce waste and enhance supply stability.

While the push to reshore manufacturing to the US faces economic hurdles, particularly for generics, investments in domestic capacity, like BASF’s new GMP plant, contribute to a more robust regional supply base.