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
3000+
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.
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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.
Sites
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
South Plainfield R&D Site
Cranbury R&D Site
Slovenia R&D and Manufacturing Site
Case Studies
MoreENT-03 GRC Poster
ENT-03 was predicted to be the mammalian equivalent of trodusquemine, based on knowledge of the bile acids produced in mammals, such as 7-HOCA. The individual C-25 isomers of ENT-03 were prepared and both detected in mouse brain. Trodusquemine and ENT-03 have both demonstrated dramatic effects in obesity and insulin resistance. (25S)-ENT-03 was selected for development for the treatment of diabetes and obesity.
More
How Porton's Expertise Enhances Mutual Benefits in License In/Out Agreements
Porton's extensive expertise in technical transfer, supply chain optimization, and regulatory affairs (RA) knowledge significantly benefits both parties involved in license in and out scenarios.
More
News
MoreNews2024-10-14
Driving innovation and excellence in the CDMO industry, Porton Pharma Solutions 2024 CPHI Europe Review
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News2024-10-10
Connect with Porton J-STAR at AAPS PharmSci 360 2024 @ Booth 2431
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Technical Enability | Porton’s Team of Global Chemical Engineering and Technology Published Breakthrough Results in Crystal Growth & Design and reported them at the 2024 Crystal Engineering Gordon Research Conference
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Presenter Profile Reveal, Meeting Your CDMO Experts In Booth 5C17
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Porton Showcases At CPhI Europe, Meeting Your CDMO Experts In Booth 5C17
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News2024-09-13
Keep hope alive! We invite you to stay tuned to DMD
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