Facilities

Tyrone, Pennsylvania

RSMs and Registered Intermediates

Albemarle manufacturing facility in Tyrone, Pennsylvania 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.

Unique capability

Albemarle 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, Albemarle is the only facility in North America with the ability to back-integrate RSMs. 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 manufacture

The combination of Tyrone and South Haven 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 Albemarle 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.

Tyrone
  • R&D_Icon-1

    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

    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 Nutsche filters

    Support Equipment

    • Dryers (rotary, Littleford®)
    • Wiped film evaporators (glass, stainless steel)
  • Large_Scale_Commercial_Icon

    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
    • Rosenmund® Nutsche filters
    • Rotoform

    Support Equipment

    • Dryers (rotary, Littleford®, fluidized bed), glass, stainless steel
    • Wiped film evaporators (glass, stainless steel), 1mmHg
    • Distillation columns (glass and alloy up to 20 stages)
    • Solvent drying
  • Analytical_Support_Icon

    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 (400 MHz)
    • HPLC MS
    • UPLC

Facilities

South Haven, Michigan

Our South Haven, Michigan facility is a full-service cGMP manufacturing site, containing everything required to develop APIs to commercialization, with all the necessary support capabilities.

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