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Bourgoin, France
Oral solid dose
Our Bourgoin, France facility is an FDA-approved center of excellence specializing in the early and late-stage development and commercial manufacturing of oral solid dose (OSD) products, with a particular focus on high-potency active pharmaceutical ingredients (APIs).
Early development hub
This new 430-square-meter dedicated R&D hub is equipped with state-of-the-art equipment and technologies to support formulation development and mature product characterization of oral solid dose forms. Our cutting-edge capabilities enable customers to accelerate their time-to-market by facilitating smarter decision-making, minimizing experimental efforts, and reducing risks.
Benefits include:
- Integrated API characterization, solid-state analysis, drug product development, clinical services, and regulatory support to accelerate time to clinic and market
- Streamlined supply chain management to help customers avoid costly delays
- Optimized manufacturing and scale-up processes to accelerate milestones
- Fewer tech transfers and enhanced site communication to optimize timelines
Broad range of services
Our Thermo Fisher Scientific facility in Bourgoin provides early and late-stage development and commercial manufacturing of oral solid dose (OSD) products, with a specialization in high-potency APIs.
Specialized capabilities:
Areas of expertise include:
- Expertise in the early development of oral solid dose formulations
- Specialization in handling highly potent APIs up to category 3B, including cytostatic
- Comprehensive packaging solutions including bottles, blisters, and high-speed lines
- Proven success in the transfer and commercialization of development projects globally
- Versatile manufacturing capabilities for tablets, capsules, powders, and granules
- Experience in producing orphan/niche and pediatric indication products
- Capacity to support commercial supply from small to large scale
This site features a strong regulatory inspection history with all major international regulatory agencies. We are continuously investing in both capital and scientific resources to enhance our capabilities.
To learn more about our specific equipment and capabilities, download our site fact sheet.
Helpful Resources
Whitepaper
Expediting early-phase development of small molecules: An integrated approach
Small molecule drug development has changed substantially in recent years. With the heightened focus on molecularly targeted therapies, small molecule active pharmaceutical ingredients (APIs) and drug products are more complex and potent than ever, requiring increasingly specialized
manufacturing processes and drug delivery solutions. At the same time, the competitive demand for rapid entry into clinical development—combined with accelerated review pathways—translate into compressed manufacturing and delivery timelines.