IND-enabling CMC Project Experiences
Our Services
We provide a fully integrated, one‑stop platform for messenger RNA (mRNA) applications, with CMC capabilities to accelerate timelines and ensure high‑quality output at every step: from plasmid DNA (pDNA), linearized DNA, IVT‑mRNA, lipid nanoparticle (LNP) encapsulation, to targeted LNP (tLNP) antibody conjugation.
Accelerating mRNA Programs
Preclinical
- PD-grade manufacturing and release to support preliminary assessments and animal studies
IIT/IND
- Process development & optimization
- Analytical development and qualification
- GMP production
- Product characterization and quality control
- Stability studies
- Regulatory & Filing support
Clinical Phases
- Process transfer
- Comparability studies
- Clinical-grade sample manufacturing
- Aseptic process simulation
- Stability studies
BLA/Commercial
- Process characterization (CQA\CMA\CPP)
- Method validation
- Process validation & PPQ
- On-site inspection support
- GMP production and stability studies
Successful GMP Batches Delivery
IND-enabling CMC from Plasmid to mRNA-LNP Pilot Scale Production Release
PD & GMP Facility for RNA & LNP Manufacturing
Related Resources
FLYER
One-Stop mRNA Vaccine Solution for IND Filing– in as Little as 5 Months
Accelerated timeline using FDA/EMA ready CMC.
WHITE
PAPER
PAPER
CMC Process Challenges and Solutions for Targeted Lipid Nanoparticles (tLNPs)
Utilizing mRNA-tLNP for in vivo CAR-T application with advanced conjugation technologies.
FLYER
One-Stop Solution for Cell Therapy
One-stop Solution RNA-tLNP IND-enabling CMC for in vivo CAR-T applications.
WHITE
PAPER
PAPER
Overcoming the Manufacturing Challenges of Circular RNA
Adapt your circRNA platform to ensure efficacy, safety, product purity and robust process scale-up.
Frequently Asked Questions