White Paper & Case Study: Fast Path to Market: Going from GMP1 to PPQ in Just 12 Months

This white paper details a landmark project and case study undertaken jointly at Rentschler Biopharma’s Milford, Massachusetts and Laupheim, Germany, facilities, where the company successfully compressed the typical biopharmaceutical development timeline to achieve process performance qualification (PPQ) from good manufacturing practice (GMP) initiation in just 12 months — a process that conventionally takes 15 to 18 months. This achievement not only highlights Rentschler Biopharma's expertise in rapid biopharmaceutical development but also underscores its strategic capability to meet aggressive market demands, and is further notable given that this was the first PPQ project undertaken at the Milford facility. 

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 development and manufacturing partner that could navigate complex regulatory landscapes efficiently while maintaining the highest standards of quality and compliance. Rentschler Biopharma, with its dual-site capabilities spanning the United States and Europe, was uniquely positioned to rise to this challenge. 

Read this white paper to learn more about how this project showcased innovative approaches to several key processes: 

• Process optimization: Rapid adaptation and optimization of chromatography processes, crucial for ensuring product purity and scalability. 

• Global collaboration: Leveraging expertise from both the Milford and Laupheim sites, Rentschler Biopharma demonstrated exceptional inter-site collaboration, aligning global resources to enhance process efficiencies and expedite development. 

• Regulatory excellence: The project adhered to stringent FDA guidelines from inception through completion, with the PPQ phase meticulously validating the production process to ensure consistent, high-quality outputs. 

Download white paper here: