Hovione to Install World's First ConsiGma CDC Flex in New Jersey

The new hardware, developed in partnership with GEA, allows for both continuous and batch manufacturing with throughputs ranging from 1 to 200 kg/h. By enabling the transition from 1.5 kg development samples to full-scale commercial batches on a single line, the platform eliminates the need for traditional scale-up procedures. The system is designed to handle highly potent compounds with containment capabilities up to 1 µg/m³.

David Basile, Vice President of Technical Operations for the Americas, noted that the installation integrates the East Windsor site into a unified workflow. This allows pharmaceutical partners to move from initial formulation to finished tablets without switching facilities or quality protocols. The move aligns with the industry's shift toward continuous manufacturing, supported by the ICH Q13 regulatory framework. As of 2024, the FDA has approved 17 products utilizing such guidance, signaling a broader adoption of real-time quality monitoring and automated process controls across the pharmaceutical sector.