Small Molecules CDMO Services
As a global CDMO (Contract Development and Manufacturing Organization) provider, Porton offers efficient, flexible, and high-quality solutions for custom development and production of small molecule APIs, as well as technical services throughout the entire lifecycle from pre-clinical to commercial to our worldwide partners.
2000+
Total Capacity (m³)
1000+
Global Customers
3500+
Milestone Projects
Our Services
Drug Substance
Capability
Drug Substance
Capacity
Drug Product
Capability
Drug Product
Capacity
Capability
Process Design, Route Scouting, Development, and Optimization for APIs and Intermediates
Non-GMP and GMP Manufacturing from Pre-clinical to Commercial for APIs and Intermediates
Pre-formulation Research and Process Development & Optimization
Pre-Clinical and Commercial Batches GMP Manufacturing for Drug Product
DS-DP Co-processing
Comprehensive Analytical R&D and Quality Control
IND/NDA Dossier and CMC Solutions
Capacity
| Site |
Reactor Volume (m³) |
Reactor Volume Range (L) |
Number of Reactors |
Temperature Range (°C) |
Reaction Pressure (Mpa) |
Description |
| Shanghai Fengxian | 75.5 | 200 to 6,300 | 46 | -80 to 200 | -0.1 to 5 | GMP/HP |
| Chongqing Changshou | 834.3 | 5 to 10,000 | 323 | -90 to 200 | -0.1 to 5 | GMP |
| Jiangxi Yichun | 519 | 200 to 5,000 | 197 | -70 to 140 | -0.1 to 1.6 | GMP |
| Hubei Xiaogan | 565 | 1.000 to 6,300 | 118 | -100 to 150 | -0.1 to 0.6 | non-GMP |
|
J-STAR South Plainfield |
1 | 5 to 100 | 18 | -80 to 200 | -0.1 to 0.095 | GMP/HP |
| Total | 1,997.8 | 5 to 10,000 | 702 | -100 to 200 | -0.1 to 5 |
Capability
Pre Formulation
Physical Characterizations
Polymorph & Salt Selection
Excipient Compatibility
Enabling Technology
Spray Drying
Hot Melt Extrusion
Nano-milling
Emulsification
Ai Aid Prediction
In-vivo Modeling
Statistical Modeling
Oral Platform
Oral Immediate Release
Oral Modified Release
Oral Instant Release
Sterile Platform
Injectable
Lyophilized Powder
Complex Injectable
Topical Platform
Semisolid
Hydrogel Patch
TTS Patch
Capacity
OSD (Tablet & Capsule)
1 B doses/year
High Potent: 60 M doses/year
Injectable
Ampoule: 30M units/year
Small Volume Injections: 25 M units/year
Lyophilized Powder Injections: 3.3 M units/year
Semisolid
Gel Patch: 35 M patches/year
Cream/Ointment/Gel Paste: 16 M Tubes/Year
End-to-end Solutions
Early Development
Late Development
Commercial Supply
Analytical Solution
Chemistry Research Unit (CRU)
- Discovery Synthetic Chemistry
- Discovery Process Chemistry
- Building Blocks Development
IND Enabling
- Process Optimization
- Solid Form Screen & Selection
- Quality Study
- Impurity Study
- non-GMP & GMP Deliveries
DS-DP Integration
- Leveraging our expertise in APIs and advanced crystallization technology, we have established a DP technology platform that offers integrated services from DS to DP.
Implementation of QbD Concepts
-
Final Process Development:
-Ideally Performed Before PhIII or Reg Campaigns; Reduce PMI
-Quality Improvement
-Plant Fitness Assessment
-
Justification of the Specs of RSM and Intermediates:
Study the formation, fate, and purge of impurities from the RSM synthesis, and establish RSM specs based on the purge studies of these impurities in downstream processes.
-
Quality Risk Assessment:
Comprehensive process characterization via DoE studies or OVAT studies, including FMEA, probability, impact, detectability, PAR, and NOR.
NPI
-
Porton provides innovative drug introduction/license out services for global customers. These projects include innovative drugs such as small molecules from preclinical to commercial stages
-
The introduction of projects of different stages, molecular types, and indications can meet the diverse needs of global customers, and Porton‘s professional scientists and business development team will help customers improve the development speed of projects, enrich R&D pipelines, and expand product portfolios. In order to fully meet the different needs of global companies, Porton proposes a cooperation business model, reducing the risk of introduction and achieving mutual benefit and win-win results.
LCM on Commercial Campaign
-
R&D in Commercial Campaign:
- Cost saving, time saving, and EHS purposes (such as reducing PMI) and troubleshooting.
- Based on the current process, optimize the process to improve yield and efficiency (such as replacing solvents, simplifying work-up, recycling materials, and other methods).
- 2nd generation process R&D.
-
We manage the product lifecycle from three different aspects:
- Continuous Cost Improvement
- Sustainable Supply Chain Management
- Capacity Planning
Porton's professional analytical R&D and QC teams provide clients with comprehensive quality research and stability study services for DS and DP that adhere to global IND/NDA submission requirements. Our extensive project experience spans from preclinical to commercial stages, covering method development and optimization, analytical method validation and transfer, physicochemical property studies, structural confirmation, reference standard characterization, product release testing, packaging material compatibility studies, stability studies, and the development of quality standards. These services are meticulously designed to meet the diverse needs of our clients at various stages of drug development.
Porton Sites
South Plainfield R&D and Manufacturing Site
Cranbury R&D and Manufacturing Site
Slovenia R&D and Manufacturing Site
Chongqing Shuitu R&D Site
Chongqing Changshou Manufacturing Site
Chongqing DP Manufacturing Site
Shanghai Minhang R&D Site
Shanghai Fengxian Manufacturing Site
Jiangxi Yichun Manufacturing Site
Hubei Xiaogan Manufacturing Site
Case Studies
More
Preformulation Strategy- Inception to Completion
Drug discovery is an exceedingly complex process. Discovering a new chemical entity is in itself a huge accomplishment, which is often possible only after almost two decades of hard experimental work as well as advanced simulation efforts. Therefore, the next stage of the process, determination of toxicity becomes even more crucial as most new chemical entities (NCE) are disqualified if the NCE shows a potential toxic effect, despite any possible therapeutic effect.
More
Facilitating PROTAC Drugs Development with Innovative Processes
The PROTAC technology, through an innovative mechanism of "degradation rather than inhibition," provides a new pathway for targeting traditionally undruggable proteins and addressing resistance issues.
More
