Ferro Pfanstiehl Laboratories - High Potency API Development and Manufacturing

FPL's strategic focus is the development and manufacturing of pre-clinical, Phase I-III and approved High Potency Active Pharmaceutical Ingredients (HPAPI). Ferro Pfanstiehl's fully integrated product development team has over 200 years of collective API development and commercial scale experience.

HIGH POTENCY ACTIVE PHARMACEUTICAL INGREDIENTS (HPAPI) DEVELOPMENT AND CONTRACT MANUFACTURING

Ferro Pfanstiehl (FPL) can bring your proprietary HPAPI to market cost effectively. Whether it's an anti-cancer, anti-viral, CNS-active, cytotoxic or specialized targeted therapeutic API, FPL's High Potency Substance (HPS) development and manufacturing facility has the appropriate staff and equipment necessary for CGMP development, synthesis, purification and packaging in quantities from sub-kilogram to 40kg/lot quantities.

ICH Q7A COMPLIANT CAPABILITIES

FPL's fully integrated API development services include the full compliment of ICH Q7A compliant capabilities:

• Chemical process development and optimization
• Analyical raw material, in-process and API release assay development and validation
• API impurity profiling and identification
• Reference standard preparation and full characterization
• In-process marker identification
• Stability indicating and cleaning method development and validation
• API stability program chambers
• Regulatory affairs documentation suitable for inclusion in US/EU CMC submission packages
• Chemical engineering
• CGMP manufacturing expertise

HPAPI CONTAINMENT CHEMISTRY FACILITY

FPL's HPAPI containment chemistry facility features:

• Commercial production in 25gal to 300gal multi-purpose reactor trains
• Total primary glass-lined reactor capacity of 1,200gal
• Aurora filter dryers and tray dryers
• Safebridge-certified containment and class 100,000 product finishing areas
• Quadro co-mill based API milling capability in a dedicated HPAPI milling suite
• Small volume clinical API manufacturing in dedicated glassware
• Carlisle level IV containment isolator for small scale HPAPI finishing (filtration, drying, milling and packaging)
• Glycol single media heating / cooling system (-20°C to 120°C)
• Explosion proof rated electrical systems with full emergency backup systems
• Validated USP purified water meeting WFI limits for endotoxins
• Validated and CFR Part 11 compliant process control system

HPAPI FULL CONTAINMENT KILO LAB

A new HPAPI full containment kilo lab is under construction and scheduled for commissioning in Q1 2006 to further enhance customer service to clients with pre-clinical and phase I-II clinical HPAPIs, as well as other small-molecule APIs and advanced intermediates. The new facility will feature single fluid heating and cooling capabilities, a multi-purpose 50L and 100L Hastelloy based configuration and a separate 100L CGMP full containment hydrogenation capability.

ANALYTICAL SERVICES LABORATORY

Ferro Pfanstiehl's new and fully equipped analytical services laboratory was commissioned in May 2004. Capabilities include analytical test method development, test method validation, CGMP release testing and API stability testing.

Key instrumentation capabilities include: HPLC (RI, UV, LSD and PDA detectors), GC headspace analyzer for residual solvent analysis, UV / visible, FTIR, Total Organic Carbon (TOC) analyzers, polarimetry, differential scanning calorimeter, ICP metal detection, NMR, LC / MS, ICH Q7A-compliant stability chambers, endo-toxin and microbial testing, 21 CFR part 11-compliant analytical services lab.

QUALITY ASSURANCE

Ferro Pfanstiehl has an excellent ICH Q7A based quality assurance platform, with all the appropriate quality system policies and procedures required for compliance with the FDA, the EMEA and other global regulatory agencies. Ferro Pfanstiehl provides drug master file preparation and maintenance services, or CMC documentation suitable for direct inclusion in your regulatory submissions. FPL maintains more than 20 active drug master files covering both type II and type IV requirements and has successfully undergone both general and FDA driven API pre-approval inspections.

See also Pharmaceutical Technology - Ferro Pfanstiehl Laboratories - API Chemical Process Development and Manufacturing

See also Pharmaceutical Technology - Ferro Corporation - Particle Technology For Drug Delivery, Supercritical Fluids: Nanoparticles, Microparticles Controlled Release, Inhalation, Proteins And Polymers