Drug Substance Manufacturing
BioDuro provides an end-to-end drug substance manufacturing network spanning regulatory starting materials, advanced intermediates, GMP kilo lab production, and late-stage commercial API manufacturing.
Facilities in Shanghai, Bengbu, and Taiwan provide the scale, technical expertise, and quality oversight needed to support programs as development and supply requirements evolve.
RSM & Intermediate Manufacturing
BioDuro’s Bengbu facility supports large-scale production of regulatory starting materials and advanced intermediates, providing a reliable foundation for downstream API manufacturing.
- 130,000 L total reactor volume
- 6 pilot-scale production lines
- 2 commercial-scale production lines
GMP API Kilo Lab
Shanghai-based kilo lab operations connect process development with GMP production, supporting rapid and compliant scale-up for Phase I and Phase II programs.
- 9 GMP kilo lab reactors
- 6 production lines with Class D clean rooms
- Integration from R&D through kilo lab production
Late-Stage Commercial GMP API
Through BioDuro’s joint venture with Cenra API Solutions, the Taiwan facility supports late-stage clinical and commercial cGMP API manufacturing.
- 8 GMP production lines
- 2 pilot-scale anbd 6 commercial-scale lines
- 356,000 L total reactor volume
- Up to 200 tons maximum annual single-line production
