API CDMO
InquiryProtheragen works with an extensive worldwide network of leading CDMO partners. Our strategic alliance with CDMO experts and facilities enables us to offer our clients integrated and highly flexible small-molecule development and manufacturing services. From early stage process development to GMP production and large scale commercialization, we partner with the most qualified and experienced service providers to ensure you receive end-to-end solutions.
Tailored Solutions at Every Stage
By collaborating with specialized facilities across regions, we are able to provide our clients with customised services throughout the drug development process.
R&D Center
50,000+ sq. ft. with 15 synthetic labs, 80 fume hoods, and kilo-lab capabilities
R&D Center
Pilot Plant
30,000 sq. ft. GMP facility with reactors (50L-5,000L) and cryogenic (-85°C) capacity
Pilot Plant
Commercial Site
Multi-ton manufacturing suites with 20,000L reactors
Commercial Site
Quality Systems
cGMP/ISO compliance, cloud-based data management, 24/7 monitoring
Quality Systems
Our One-Stop Service
In conjunction with our CDMO partners, Protheragen offers a complete suite of services which include drug discovery, process development and optimisation, chemical process scale-up, quality control and validation, and GMP-compliant commercial manufacturing.
Our Technology Platforms
Flow Chemistry Technology Platform
Our partners are highly experienced in continuous flow chemistry for small molecules and intermediates to support the following:
- Feasibility studies (FTE/FFS) for early phase development
- Process Development & Optimisation (PD&O)
- Scale-up and proof-of-concept studies
- Design of commercial equipment
- Variable scale sample preparation
- Non-GMP and cGMP commercial manufacturing
Synthetic Biology & Biocatalysis Technology Platform
For enzyme-based transformations and fermentation-driven synthesis, we and our partners provide:
- Microbial strain improvement and optimization
- Fermentation process development and optimization
- Separation and downstream processing (DSP)
- Biotransformation and enzyme engineering
- Synthetic biology technologies
Crystallization & Particle Engineering
- Screening of different stages of crystallization
- Rapid crystallization process development
- Systematic crystallization process development from grams to kilograms
- Crystallization process optimization
- Separation of chiral compounds by crystallization
- Dry grinding and wet grinding process development
- Crystal product characterization
- Characterization of powder properties
- Crystalline stability and dissolution testing
TPD & Peptide & ADC
We coordinate with partners experienced in complex biologically active molecules to support:
- Peptide and conjugate synthesis
- TPD program development
- Scale-up and GMP manufacturing for peptide APIs and ADC payloads
- End-to-end support from early-stage research to commercialization
Quality & Compliance
Our partner CDMOs maintain high compliance standards and have passed regulatory inspections, including:
- Successful regulatory inspections (FDA, EDQM)
- NSF, Halal, Kosher, and HACCP certifications
- Multi-tier QC protocols with 3Q-validated equipment
- Supply chain diversification and raw material control
Why Partner with Us?
- Strategic Access to Global CDMO Resources
We match each project with the most suitable partner facility—saving you time and cost. - Scientific Oversight & Tech Transfer Expertise
Our internal team ensures technical continuity across all stages. - Risk Reduction Through Integrated Project Management
Dual-sourcing, regulatory navigation, and IP protection services help de-risk your development. - Multilingual, Responsive Collaboration
Our dedicated project managers coordinate communication across cultures and time zones.
By employing industry-leading flow chemistry, particle engineering and high potency API manufacturing, Protheragen allows our customers to realize the full value of integrated CDMO capabilities without having to work with or manage multiple vendors/facilities.
We provide the platform, technical oversight, and global coordination—while our partners execute flawlessly. Contact us to get started with our one-stop API CDMO service.