Capabilities
Development & Analytics
ADVANCE FROM THE LAB TO COMMERCIAL SCALE WITH TRIRX’S INTEGRATED SOLUTIONS
TriRx Pharmaceutical Services provides a range of R&D and laboratory testing services using state-of-the-art equipment and technologies in our best-in-class facilities. Drawing on our extensive experience in pharmaceutical process development labs, we can design a best-practice approach tailored to your unique product and development goals.
Each of our four facilities are equipped with an analytical laboratory for robust characterization, method development, process development, and product quality testing. This enables us to provide comprehensive process development and analytical development services for monoclonal antibodies (mAbs), recombinant proteins, peptides, vaccines, microbial-based biologics, and therapeutic modalities.
API PROCESS DEVELOPMENT SERVICES
Upstream API Process Development
- Process Screening and Optimization
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- Statistical DoE & scale-down modeling
- Small-scale bioreactors to rapidly define critical process parameters
- Media & feed screening
- Lab-scale Demonstration
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- Scale-up evaluation
- Method refinement and robustness testing
- Process
- Process Scale-up
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- Tech transfer
- Process demonstration
- Process optimization
- Scale-up studies
- Material supply
Downstream API Process Development
- High Throughput Process Screening and Optimization
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- Statistical DoE & scale-down modeling
- Scouting chromatography & filtration conditions
- Lab-scale Demonstration
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- Evaluation of lead process candidates, method optimization & refinement
- Robustness testing
- PEGylation
- Process Scale-up
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- Tech transfer
- Evaluation of lead process candidates, method optimization & refinement
- Robustness testing
- Process optimization
ANALYTICAL DEVELOPMENT SERVICES
- Chromatography testing
- Spectroscopy
- Dissolution testing
- Titre
- Stability testing & structural characterization
- Identification, purity & aggregation by USP
- Post-translational modifications
- Physical testing by USP
- Method development, validation & transfers
MICROBIAL CDMO LABRATORY CAPABILITIES
- Compendial testing
- Antimicrobial effectiveness testing
- Antibiotic assay
- Microbial identification
- Purified water testing
- Objectionable organism detection & determination