Process R&D

Ranging from route design, process improvement and optimization, process scale-up, tech transfer to commercial scale, and manufacturing of APIs and intermediates in compliance to cGMP guidelines—multi-gram to multi-ton scale.

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Process R&D

Overview

Experts in designing and developing turnkey drug substance and drug product solutions, we provide development services with flexible tailored solutions for each project. Our one-stop full service for IND application candidate compounds delivers complete API clinical trial application solutions. BioDuro operates a broad range of services from development solutions to API manufacturing in compliance with cGMP guidelines, flexible and cost-effective solutions to maximize efficiency and shorten timelines

35,000 sq. ft. large capacity laboratory space with 120 fume hoods, clean rooms, and safety evaluation labs for API production

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

Drug Substance

Process R&D Flow Chemistry Sugar Chemistry Peptide Chemistry Preparative Purification Capacity Process Safety Assessment Scale Up Synthesis Synthetic and Scale Up Chemistry DS Manufacturing Kilo and Pilot Scale Production RSM and Intermediates Manufacturing QA EHS

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