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"Fast Path to Market: Going from GMP1 to PPQ in Just 12 Months"

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Facing direct competition, a client needed to expedite the development and approval of a groundbreaking therapy. The urgency to be first to market required a partner that could navigate complex regulatory landscapes while maintaining high standards of quality and compliance. Rentschler Biopharma, with its dual-site capabilities in the United States and Europe, was uniquely positioned to meet this challenge.

This case study details a landmark project at Rentschler Biopharma’s Milford, Massachusetts, and Laupheim, Germany, facilities, where the CDMO compressed the typical biopharmaceutical development timeline to achieve process performance qualification (PPQ) from GMP initiation in just 12 months, instead of the conventional 15 to 18 months. This achievement highlights Rentschler Biopharma's expertise in rapid biopharmaceutical development and its strategic capability to meet aggressive market demands. Notably, this was the first PPQ project at the Milford facility.

The project showcased innovative approaches to several key processes:

• Process optimization: Rapid adaptation and optimization of chromatography processes to ensure product purity and scalability.
• Global collaboration: Exceptional inter-site collaboration between Milford and Laupheim, aligning global resources to enhance process efficiencies and expedite development.
• Regulatory excellence: Adherence to stringent FDA guidelines, with the PPQ phase meticulously validating the production process to ensure consistent, high-quality outputs.

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