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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R&D Process Capabilities

  • Enzymatic resolution
  • Homogeneous & heterogeneous catalysis
  • Heck, Suzuki, aromatic animation
  • Low-pressure hydrogenation (60 psig)
  • Grignard preparation and reactions
  • Thin film distillation
  • Hazardous materials handling
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Large-Scale Commercial

Reactors

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

Isolation Equipment

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

Product Finishing

  • Thin-film evaporator (1–10 gal/hr)
  • Double-cone tumble dryers (500–1,000 kg/day)
  • Assorted tray and tumble dryers (10–150 kg)

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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Pilot Plant

Reactors

  • 50 to 500 gallons
  • 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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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