Ferro Pfanstiehl Laboratories - API Chemical Process Development and Manufacturing

Ferro Pfanstiehl Laboratories (FPL) provides API chemical process development and contract manufacturing services for the pharmaceutical, biotechnology, medical and other industries. FPL supplies high potency active pharmaceutical ingredients (HPAPI), high purity low endotoxins (HPLE), injectable formulations, IV solution and advanced drug delivery products and services.

FPL has been a contract manufacturer of CGMP APIs, intermediates, injectable nutrition ingredients, specialty blocked sugars and proprietary drug delivery excipients for more than three decades. FPL now offers biopharmaceutical-HPAPI linkers, and super critical fluid-based CGMP particle sizing expertise.

CONTRACT MANUFACTURING OF HIGH POTENCY ACTIVE PHARMACEUTICAL INGREDIENTS (HPAPI)

FPL can provide you with proprietary HPAPI to market cost-efficiently. Whether it's an anti-cancer, anti-viral, CNS-active, cytotoxic or a specialized targeted therapeutic API, FPL's high potency substance (HPS) manufacturing facility has the equipment necessary for CGMP synthesis, purification and packaging in lot quantities from 1kg to 50kg.

FPL's HPAPI containment chemistry facility features:

• Commercial production in 25gal to 300gal multi-purpose reactor trains
• Total primary reactor capacity of 1,200gal
• Safebridge certified containment and class 100,000 product finishing area
• 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 processing water, meeting WFI limits for endotoxins
• Validated and CFR part 11 compliant process control system

A new HPS kilo lab is under construction and scheduled to be commissioned in Q1 2006 to further enhance customer service to clients with pre-clinical / phase I-II HPAPIs and other small molecule APIs. FPL's CGMP process scale-up development and commercial scale production services also includes non-potent APIs, advanced intermediates, proprietary injectable drug formulation ingredients and advanced drug delivery excipients. Ferro Pfanstiehl's fully integrated product development team has over 200 years of collective API development and commercial scale experience.

ANALYTICAL SERVICES LABORATORY SERVICES

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 product release testing and API stability testing. Key instrumentation capabilities include: HPLC, GC / GC with headspace analyzer for residual solvent analysis, UV / visible, FTIR, polarimeter, and ICP metal detection. FPL also has ICH-compliant stability chambers and a 21 CFR Part 11-compliant, Nu-Genesis / Agilent data capture-management system.

EXCIPIENTS, INJECTABLE SOLUTIONS AND FORMULATION INGREDIENTS

Ferro Pfanstiehl produces multi-metric ton commercial quantities of ICH-Q7A-compliant injectable drug formulation excipients, IV solution ingredients, proprietary and non-proprietary drug delivery excipients and high purity low endotoxin (HPLE) carbohydrates. FPL's leading HPLE sugar products are the disaccharide sugars, sucrose, maltose and trehalose, which uniquely meet API standards and are used preferentially to stabilize lyophilized therapeutic protein biopharmaceutical formulations.

FPL manufactures metric ton quantities of egg yolk phospholipid used for IV nutrition and liposomal / emulsion-based drug delivery formulations. FPL also produces sodium gluconate ingredients and lactate salt solutions for use in IV drugs and peritoneal dialysis solutions.

CONTRACT MANUFACTURING AND ADVANCED DRUG DELIVERY DEVELOPMENT INGREDIENT MANUFACTURING SERVICES

FPL has been a contract manufacturer of CGMP APIs, intermediates, injectable nutrition ingredients, specialty blocked sugars and proprietary drug delivery excipients for more than three decades. FPL is now offering biopharmaceutical-HPAPI linkers, and super critical fluid-based CGMP particle sizing expertise.

QUALITY ASSURANCE

FPL has an excellent ICH Q7A-based quality assurance platform, with all the appropriate quality system polices and procedures required for compliance with the FDA and other world regulatory agencies. FPL provides drug master file preparation and maintenance services, having more than 20 active drug master files covering both Type II and Type IV requirements.

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

See also Drug Development Technology - Ferro Pfanstiehl Laboratories - High Potency API Development and Manufacturing