From Lab to Launch Faster
Access Accelerated Process Performance Qualification (PPQ) at FUJIFILM Biotechnologies
This case study highlights how FUJIFILM Biotechnologies enabled an accelerated Process Performance Qualification (PPQ) for an orphan E. coli–expressed therapy, completing 3 PPQ batches within 18 months of tech transfer with high compliance. Through a streamlined PPQ-to-submission roadmap, a global cross-functional team optimized analytical validation, process characterization, and suite reconfiguration, while securing atypical, single-source cGMP materials. This “Partners for Life” approach, rooted in trust, transparency, and innovation, helped move from lab to launch faster.