Drug Substance Process Development
BioDuro-Sundia’s Process Development Services for drug substance production defines the most efficient path to manufacture your API or intermediates.
Interested in this expertise?
Our extensive services support production of API for GLP toxicology studies, IND-enabling stuidies, clinical studies and commercialization efforts.
BioDuro-Sundia leverages 14 years of experience to offer innovative, adaptable, and cost-effective process development solutions spanning:
The BioDuro-Sundia Advantage
IND-enabling and Clinical Phase Process Development Services
- Fast and reliable CRO for synthesis of APIs, intermediates, building blocks and scaffolds
- End-to-end process characterization: safety assessment, impurity profile controls, critical parameters for IND-enabling studies and GMP production
- 130,000L reactor capacity across process R&D capabilities
- On-site QA team and dedicated GMP compliant tea
- Flexible cost options: month/annual-based or quotation-based
- Integrated one-stop-shop services for IND-enabling studies
Flow Chemistry Experts
- Extensive experience with extreme reaction conditions: high temp/pressure, short intermediate residence time, and photochemistry
- Multiple types: micro-channel mixer, plug flow reactor, continuous stirring tank reactor
- Adaptable: self-made systems provide the flexibility to meet your needs
- Superior safety and consistent selectivity, impurity profile control, and scale-up
- Green chemistry reduces waste treatments
Communicative & Trusted Partner
- 285 staff, including PhDs with expertise in heterocyclic, organometallic, hazardous, nucleoside, chiral, and sugar chemistries
- Process chemists stay with projects as they move to production
- Strong track record advising clients on successful IND submissions