Recombinant Erwinia Asparaginase Production Using Pfenex Expression Technology

When worldwide supply constraints left patients with E. coli asparaginase hypersensitivity without a viable treatment option, the need for an immunologically distinct alternative became urgent. Developing one at speed, without sacrificing process rigor, required compressing CMC timelines while still achieving the expression titers and scalability needed for a Phase 3-ready process.

Using a Pseudomonas fluorescens expression platform, the development program moved from initial strain screening at 96-well scale to a GMP-transferable process in approximately 12 months. Chromosomal knockouts of the native host asparaginase, multi-condition induction optimization, and rapid scale-up from 2L to 1000L were central to achieving titers above 20g/L and producing preclinical material within three months. Project kick-off to FDA approval took approximately five years.

Explore the technical approach and timeline that made this oncology program possible.