Reading Time: 2 minutes

Producing fluorinated molecules for large-scale production of active pharmaceutical ingredients (APIs) is a highly specialized field. Incorporating fluorine into APIs can change key characteristics of the molecule, such as its metabolic stability, ability to dissolve in fats and other nonpolar solvents, capacity to bind to protein, as well as its acidity and basicity. These changes can affect the bioavailability of the drug after it’s administered to the end user. In addition, working with fluorine can be hazardous and requires precise operating conditions, special equipment and safe handling and disposal processes.

Because successfully integrating fluorine into complex APIs requires a unique level of expertise, it can be difficult for pharmaceutical companies to find a contract development and manufacturing organization (CDMO) with fluorine capabilities that operates under current good manufacturing practices (cGMPs).

Specializing in Hazardous Chemistry

AGC Chemicals has extensive experience in fluorine chemistry for the pharmaceutical industry. AGC’s technologies include direct or indirect fluorination, specializing in hazardous processes such as:

  • Using fluorine gas and hydrogen fluoride directly
  • Handling highly corrosive substances like chlorine and bromine
  • Carrying out ultralow-temperature reactions (to -100 C)
  • Conducting high-pressure and high-temperature reactions
  • Managing sulfur chemistry (odor control, etc.)

Core strengths include:

    • Fluorination technology
      • Nucleophilic fluorination
        • Halogen exchange
        • Diazo fluorination
      • Electrophilic fluorination
      • Electrolytic fluorination
    • Building blocks with fluorine components
      • Delivered from tetrafluoroethylene
      • As fluorine-containing gas components
  • C3 compounds
  • Hazardous reactions
    • Cyano
    • Diazo
    • Cl2
  • High-Potency APIs (occupational exposure limit: 1-10ug/m3)
  • General organic reactions
    • Friedel-Crafts
    • Grignard
    • Cross coupling
    • Oxidation/reduction

Plant Capacity

With cGMP plants in Chiba, Japan, and Barcelona, Spain, AGC can provide multistep synthesis of key intermediates, raw materials and APIs at yearly quantities from 100 kilograms to 100 metric tons.

The first chemical manufacturing plant (CMP) at Chiba has been in operation since 2003. It serves both commercial- and clinical-phase projects with reactor capacity of 18 m3. The second Chiba CMP opened in early 2020 to support high-volume commercial-phase manufacturing of both commercial- and clinical-phase APIs and intermediates with reactor capacity of 90 m3.

AGC Pharma Chemicals Europe in Barcelona supports both commercial- and clinical-phase manufacturing of APIs and intermediates with reactor capacity of 117 m3. It is AGC’s first FDA-registered site in Europe.

Supply Chain Partnering and Contract Manufacturing

With the combined strength of these cGMP facilities, proven experience, proprietary technologies and efficient processes, AGC can reduce pharmaceutical development time and reduce costs.

AGC offers small molecule and fluorochemical-based API contract manufacturing services for custom synthesis for clinical trials, process R&D and commercial scaleup of fine chemicals for pharmaceutical products from laboratory scale to industrial scale.

Supported by the cGMP plants in Japan and Spain and sales offices around the world, AGC also serves as a proven reliable global supply chain partner.

To learn more about AGC’s specialty fluorochemical intermediates and ingredients for pharmaceuticals, click here.

AGC Chemicals