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
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Continuous Improvement of Project Life Cycle Management, Benefiting Customers by Reducing Total Cost
Continuous Improvement of Project Life Cycle Management, Benefiting Customers by Reducing Total Cost
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Molecular Modeling and Data Science for De-risking and Cost- saving of Pharmaceutical Development
Molecular Modeling and Data Science for De-risking and Cost- saving of Pharmaceutical Development
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Agile and Fast：Enabling Rapid Market Launch of Innovative Drugs from Preclinical to Commercialization in 18 Months
Enabling Rapid Market Launch of Innovative Drugs from Preclinical to Commercialization in 18 Months
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Co-processing: Co-Precipitation Technology (CPT) for the Enhancement of Flowability and Bulk Density
Formulating compressed tablets is one of the most widely used oral solid form dosages. However, a vital first step is choosing a suitable manufacturing approach and the right excipients to support the desired therapeutic effect.
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ENT-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.
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Co-processing Series: 4. Heterogeneous nucleation (HN)
In the context of crystallization, heterogeneous nucleation occurs when crystals form on a surface rather than spontaneously in the bulk solution, playing a crucial role in controlling crystal formation and growth. When applied to Co-processing, heterogeneous nucleation on the surface of excipients enhances material properties, allowing for greater control over critical attributes such as flowability, stability, and polymorphism.
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Co-processing Series: 3. Adsorption
This method involves the absorption of a dissolved drug into the pores of a carrier material, known as an adsorbent, with the drug remaining embedded in the porous media post-drying.
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Co-processing Series: 2. ASD - How Co-Processing can replace Spray Drying
With spray drying, a prevalent method for producing amorphous solid dispersions (ASD), the process involves rapidly drying a solution with hot gas, resulting in high energy consumption and significant infrastructure and operational costs.
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Co-processing Series: 1. What is co-processing and how is the industry embracing it?
Co-processing enhances the flow and density properties of active pharmaceutical ingredients (API) thus simplifying oral solid formulation. In some cases, co-processing can be used to generate Amorphous Solid Dispersion and offers more expeditious alternatives to traditional methods such as spray drying, nano-milling, or hot-melt extrusion.
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