RSMs and Registered Intermediates

Grace’s Fine Chemical Manufacturing Services’ facility in Tyrone, Pennsylvania (CDMO) has more than 40 years of history in custom manufacturing. It offers a blend of chemistry and engineering, more than 80,000 gallons of reactor capacity, the ability to develop continuous processes, and handling of highly hazardous materials as a CDMO.

Unique Capability

Grace’s FCMS uses this site to manufacture registered starting materials (RSMs), and it has the capability to produce non-cGMP pharmaceutical intermediates. In fact, through the Tyrone facility, Grace’s FCMS has the unique ability to back-integrate RSMs within North America. Tyrone is particularly well equipped for complex, multi-step synthesis with various materials of construction and covering almost every unit operation available. We also have the capability to handle cryogenic reactions down to –90ºC.

Integrated Domestic Custom Manufacture

The combination of Tyrone and South Haven custom manufacturing facilities offers U.S. companies the chance to outsource drug substance domestically and structure a simplified supply chain, mitigating the risk of going overseas to source starting materials.

This capability is further supported by the long tenures that Grace FCMS has at both sites and the way the highly experienced teams work together. South Haven provides support for quality assurance across both sites, and the quality management system at Tyrone is aligned to meet FDA and ICH requirements.

Custom Manufacturing Facility - CDMO

Full Scale US CDMO Pharma
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    R&D Capabilities

    • Nine chemists on site (2 Ph.D., 1 MS, 5 BS)
    • Average tenure exceeding 15 years
    • Fume hoods, walk-in hoods
    • Glassware up to 22L
    • Lab-scale wiped film evaporator (glass)
    • Lab-scale high-pressure reactors (300 mL to 4 L)
    • High-throughput parallel reactor system
    • Glove box
  • Plant_Icon (1)

    Pilot Plant

    Reactors

    • 30 to 500 gal (100 - 1,900 L)
    • Glass-lined
    • Up to ~250 PSI
    • Temperatures –90ºC to 250ºC

    Isolation Equipment

    • Centrifuges
    • Agitated filter/dryers

    Support Equipment

    • Dryers (rotary)
    • Wiped film evaporators (glass, stainless steel)
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    Commercial Manufacturing

    Reactors

    • Over 80,000 gallons (300,000 L) of capacity
    • Sizes range 500 to 4,500 gallons (1,900 - 17,000 L)
    • Glass-lined, stainless steel and Hastelloy® alloy, nickel, zirconium
    • Up to ~150 PSI

    Isolation Equipment

    • Centrifuges, belt filters and filter presses
    • Agitated filter/dryers
    • Rotoform® pastillator

    Support Equipment

    • Dryers (rotary, horizontal plow dryer), glass, stainless steel
    • Wiped film evaporators (glass, stainless steel), 1mmHg
    • Distillation columns (glass and alloy up to 20 stages)
    • Solvent drying
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    Analytical Support

    Equipment

    • Numerous GCs (HP 6890, 6850, 7890), equipped with auto samplers PID, TCD Headspace
    • Numerous LCs (HP 1100, 1200) equipped with auto samplers
    • NMR Bruker® 400 MHz
    • HPLC MS
    • UPLC

HASTELLOY® is a trademark, registered in the United States and/or other countries, of Haynes International, Inc. ROTOFORM® is a trademark, registered in the United States and/or other countries, of IPCO GERMANY GMBH. BRUKER® is a trademark, registered in the United States and/or other countries, of Bruker-Physik GmbH. This brochure is an independent publication and is not affiliated with, nor has it been authorized, sponsored, or otherwise approved by the aforesaid companies.

 

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