south haven cgmp facility boosts pharma manufacturing capabilities
TRANSCRIPT
SOUTH HAVEN OVERVIEW
• More than 32 years service in pharmaceutical and chemical industry
• Substantial R&D and new product development resources
• cGMP kilo lab and pilot plant to support customer product development
• Extensive custom manufacturing equipment and chemistry capabilities
• On-site analytical support and methods development in a FDA-regulated facility
COMMERCIAL MANUFACTURING
Our South Haven facility is fully equipped to:
• Custom manufacture drug intermediates and APIs for the branded pharmaceutical industry;
• Develop, manufacture and sell APIs to the generic pharmaceutical industry;
• Manufacture non-pharmaceutical materials under cGMP conditions; and
• Meet your needs for a wide range of product applications, including:
> Anti-inflammatory > Anti-psychotic
> Antifungal > AIDS treatment
> Cardiotonic > And many more
> Cancer treatment > Neutraceuticals
Albemarle has been a committed partner to the pharmaceutical and
chemical industries for more than 30 years. You may know us for our bulk manufacture
of active APIs such as ibuprofen and propofol. Or you may have heard about our growing toolbox of custom
synthesis capabilities.
With our 2006 acquisition of a full-service pharma manufacturing facility in Michigan, Albemarle is now an even
more attractive custom services partner for your pharmaceutical and registered starting material needs.
Our South Haven site strengthens Albemarle’s ethical and OTC pharmaceutical portfolio with additional
chemistries; smaller, more flexible equipment; and a slate of commercial products.
WORLD-CLASS R&D LAB
Chemists and Equipment:
• A highly skilled large R&D team averaging more than ten years’ working experience in chemical or pharma R&D laboratory, kilo laboratory and pilot plant
• Fully equipped R&D laboratory
• cGMP kilo laboratory with walk-in and bench fume hoods
• NMR, HPLC, LC-MS, GC, GC-MS, FTIR and more
• High-throughput parallel reactor systems to facilitate FDA Q8 compliance
Process Capabilities:
• Enzymatic resolution
• Homogeneous & heterogeneous catalysis
• Heck, Suzuki, Aromatic amination
• Low-pressure hydrogenation (60 psig)
• Grignard preparation and reactions
• Thin film distillation
• Hazardous materials handling
South Haven: cGMP facility boosts pharma manufacturing capabilities.
ON-SITE PILOT PLANT
Reactors
• Size of reactors: 50 to 500 gallons
• Materials of construction: glass-lined, stainless steel and Hastelloy® alloy
• Temperature capability: -80C to 250C
Isolation Equipment
• Top-loading centrifuge
• Nutsche filter dryer
• Aurora™ filter dryer
• Agitated filter dryer
Product Finishing Equipment
• Thin-film evaporator
• Double-cone tumble dryer
• Vacuum tray dryer
• Small tumble dryer
LARGE-SCALE COMMERCIAL CAPABILITIES
Reactors
• 60,000+ gallons of reactor capacity organized in three sections
• Size range 1,000 to 4,000 gallons
• Glass-lined (~70%), stainless steel, and Hastelloy alloy
• Temperature range: -20C to -190C
Isolation Equipment
• Heinkel® centrifuge (20–200 kg/hr, automated)
• Top-loading centrifuge (5–50 kg/hr, manual)
• Nutsche filter dryer (batches up to 20 kgs)
Product Finishing Equipment
• Thin-film evaporator (1–10 gal/hr)
• Double-cone tumble dryers (500–1000 kg/day)
• Assorted tray and tumble dryers (10-150 kg)
Utilities
• Steam, cooling tower, chilled water, low-temperature Dowtherm™ fluid
• Compressed and breathable air, USP water, N2, H2
• Bulk tanks for solvents, acids and alkalis
• Hot oil and Cryo systems
ANALYTICAL SUPPORT
Equipment
• Gas chromatographs
• High-pressure liquid chromatographs
• Mass spectrometers: 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, and many more
Analytical Services Capabilities
• Methods development and validation
• Technical transfer of methods
• Stability studies and stability indicating methods
• Cleaning studies and validated methods
A RECORD OF FDA COMPLIANCE
• On-site analytical support and methods development in a cGMP, FDA-regulated facility
• Record of compliance with FDA and other regulatory bodies complements Albemarle’s Orangeburg site, which is ISO 9001-certified and has been recognized by SOCMA and NPRA for safe operations
The information presented herein is believed to be accurate and reliable, but is presented without guarantee or responsibility on the part of Albemarle Corporation. It is the responsibility of the user to comply with all applicable laws and regulations and to provide for a safe workplace. The user should consider any information contained herein, including information about any health or safety hazards, only as a guide, and should take those precautions that are necessary or prudent to instruct employees and to develop work practice procedures in order to promote a safe work environment. Further, nothing contained herein shall be taken as an inducement or recommendation to manufacture or use any of the herein described materials or processes in violation of existing or future patents.
Find out how we say yes to hundreds of fine chemistry projects annually.
Albemarle is experienced and equipped to provide high-quality APIs to pharmaceutical customers worldwide.
To experience the difference of a committed fine chemistry partner, contact your Albemarle Representative.
www.albemarle.com
A M E R I C A S
Fine Chemistry Services
Tel: +1 225 388 7402
E U RO PE , M I D D L E E A ST, A F R I C A
EMA Fine Chemistry Services
Tel: +32 10 48 1711
FCS-0001 (01/11)