IND Clearances
IND-Enabling CMC Service
Cell Line
Development
Upstream
Process
Development
Downstream
Process
Development
Formulation
Development
Analytical
Method
Development
Drug
Substance
Manufacturing
Fill and Finish
Regulatory
Services
IND-Enabling CMC Services
Established one-stop biologics development and manufacturing capabilities.
High-Concentration Protein Formulation
Proven customized multimodality solutions for critical challenges.
200–500L Drug Substance Manufacturing
Fully single-use GMP manufacturing with zero-crossover production lines, aligned to global regulatory standards.
CMC/CMO Projects Delivered
GMP Batches Successfully Completed
Resources
FLYER
Accelerate Your Path to IND with ExpressCMC
Achieve tox batch in as fast as 4 months with our integrated DNA-to-IND platform.
WHITE
PAPER
PAPER
High-Concentration Formulation
Address viscosity and stability challenges for clinical-ready biologics.
BROCHURE
IND-Enabling CMC Strategy for Biologics
A comprehensive overview of CMC development from gene to IND submission.
POSTER
Integrated DNA-to-IND Workflow Overview: ProMax and ExpressCMC
Visualize the complete development pathway and key acceleration points.
Frequently Asked Questions