Small Molecules CDMO - PORTON



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    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

      3500+

      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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