CN
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.

Contact Us

    2000+

    Total Capacity (m³)

    1000+

    Global Customers

    3000+

    Milestone Projects

Our Services

    Drug Substance
    Capability
    Drug Substance
    Capacity
    Drug Product
    Capability
    Drug Product
    Capacity
Drug Substance
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

Drug Substance
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
Drug Product
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

Drug Product
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
Early Development
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.
Late Development
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.

Commercial Supply
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

Analytical Solution

    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.

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ⓒ 2024 PORTON Legal Notices | Porton Privacy

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