Overview
BioDuro provides process development services with expertise in the design and developement turnkey drug substances and
orally administered drug products. We offer process R&D service capabilities tailored to each client's needs, with flexible and cost-effective solutions to maximize efficiency and shorten timelines.
In compliance with cGMP guidelines, our one-stop shop for process development and IND application encompasses active pharmaceutical ingredients (API), intermediates and regulatory starting materials (RSM) for a variety of small and large molecule modalities. Our 35,000 sq. ft. facility is equipped with 120 fume hoods, clean rooms, and safety evaluation labs for API production streamlines client pipelines by accomodating both small-scale process R&D and large-scale manufacturing.
Click here to download the PDF version of our early-to-late stage drug substance process development services flyer. Route Design and Evaluation
Design and evaluate potential synthetic routes
Carry out material and production cost analysis of each route
Process Optimization
Condition screenings
Modification work-up and isolation process
Process Characterization
Impurity profile controls (purge/fate)
Characterize critical parameters (IND enabling)
Safety assessment and PGI impurity controls
Scale-up Demonstration
Demonstrate the process on kilo scale
Reaction Engineering
Isolation and crystallization studies such as solvent screening, solvent selection, and solubility studies
Impurity profile controlling such as impurity structure elucidation and impurity purge/fate