Facilities

South Haven, Michigan

cGMP Development & Manufacturing

Albemarle’s South Haven, Michigan site is a full-service cGMP manufacturing facility. The site has served the pharmaceutical drug substance market for over 40 years, and contains everything required to develop APIs to commercialization and provide all the support capabilities you may need.

Efficient scale-up

Alongside substantial R&D capacity and resources for new product development, there is a cGMP kilo lab and pilot plant to support scale-up. We also have extensive custom manufacturing capability up to commercial volumes. On-site analytical teams at the FDA-regulated facility support method development.

South Haven is fully equipped to develop and manufacture custom drug intermediates and APIs, which we have done to serve therapeutics in a wide range of indications. We have high-throughput parallel reactor systems to facilitate FDA Q8 compliance.

 

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    Pilot Plant

    Reactors

    • 50 to 500 gallons (190 to 1,900 L)
    • Glass-lined, stainless steel and Hastelloy® alloy
    • Temperatures –20ºC to 160ºC

    Isolation Equipment

    • Top-loading centrifuge
    • Nutsche filter dryer
    • Aurora™ filter dryer

    Product Finishing

    • Thin-film evaporator
    • Double-cone tumble dryer
    • Vacuum tray dryer
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    Large-Scale Commercial

    Reactors

    • 60,000 gallons (227,000 L ) of capacity organized in three sections
    • Sizes range 1,000 to 4,000 gallons (3,800- 15,000 L)
    • Glass-lined (70%), stainless steel and Hastelloy® alloy
    • Temperatures –20ºC to 190ºC
    • Hydrogenation (up to 150 psig / 10 bar)

    Isolation Equipment

    • Heinkel® centrifuges 20–200 kg/hr (40-400 lb/hr) automated
    • Top-loading centrifuge 5–50 kg/hr (10-100 lb/hr) manual
    • Nutsche filter dryer (batches up to approximately 200 kg/400 lb)

    Product Finishing

    • Thin-film evaporator 1–10 gal/hr (4-40 L/hr)
    • Double-cone tumble dryers 500–1,000 kg/day (1,100-2,200 lb/day)
    • Assorted tray and tumble dryers 10–150 kg (20-300lb)

    Utilities

    • Steam, cooling tower, chilled water, low-temperature coolant
    • Compressed and breathable air, USP water, N2, H2
    • Bulk tanks for solvents, acids and alkalis
    • Hot oil and cryo systems
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    R&D Process Capabilities

    • Enzymatic resolution
    • Homogeneous & heterogeneous catalysis
    • Heck, Suzuki, aromatic animation
    • Low-pressure hydrogenation (60 psig/ 4 bar)
    • Grignard preparation and reactions
    • Thin film distillation
    • Hazardous materials handling
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    GMP KILO LAB

    • Development & Walk-in Hoods with flexible setup ability
    • 2 x 25L, 50L, and 100L Glass Vessels
    • Aurora and 30L Glass Bucchi Nutsche Filters
    • Reactors monitored via Distributed Control System
    • Additional 50L reactor and 25L mixing vessel available
  • Analytical_Support_Icon

    Analytical Services

    Equipment

    • Gas chromatography
    • High-pressure liquid chromatography
    • Mass spectrometry: GC-MS and LC-MS
    • NMR Bruker® 300 MHz multi-nuclear
    • FTIR, UV spectrophotometer, KF titrator, polarimeter, melting point apparatus, laser diffraction particle size analyzer, RC1 reaction calorimeter

    Services

    • Methods development and validation
    • Technical transfer of methods
    • Stability studies and stability indicating methods
    • Cleaning studies and validated methods

Facilities

Tyrone, Pennsylvania

Our Tyrone, Pennsylvania facility has more than 40 years of history in custom manufacturing and is where we develop or reverse integrate RSMs under non-GMP conditions.

Learn more