Product/Service

API Contract Development and Manufacturing

Source: Pfanstiehl, Inc.

Pfanstiehl is a global leader in the manufacture of cGMP-produced, high purity, injectable grade excipients and bioprocessing solutions.  The majority of leading biopharma firms trust Pfanstiehl to supply them with critical formulation components for their commercial manufacturing needs.

Key Technology Areas of Focus - cGMP

Focused on cGMP quality Pharmaceutical and Biopharmaceuticals in many different areas.

Pharmaceutical:

  • Development and manufacturing of API and HPAPI
  • Advanced intermediates
  • Potent / Cytotoxic compounds
  • Linker-Toxins to support ADC manufacture
  • Nucleoside chemistry – Generic APIs

Biopharmaceutical:

  • Carbohydrate Chemistry / Rare and Blocked Sugars
  • Protein Stabilizers / Parental Grade Excipients
  • Bioprocessing Components
  • Drug Delivery / Solubilizers
  • Vaccine Stabilizers
  • Lyoprotectants

Process Development to Commercialization

Process Development to Commercialization From concept to commercial production, from grams to multi-metric ton quantities.

  • Process development
  • Analytical development
  • Scale up – engineering / safety
  • cGMP API / HPAPI manufacturing
  • Quality control
  • Quality assurance
  • Regulatory affairs
  • Dedicated project management

cGMP Synthesis Experience

Vast experience in a wide array of synthesis.

  • Pentoses
  • Hexoses
  • Disaccharides
  • Trisaccharides
  • Polysaccharides
  • Amino Sugars
  • Deoxy Sugars
  • Sugar Alcohols
  • Glycosides
  • Blocked Sugars and Derivatives
  • Thioglycosides
  • Nucleosides and Intermediates
  • Peptides
  • Oligosaccharides
  • Lactic Acids and Salts
  • Egg Phospholipid Extraction/Purification
  • Proprietary and Generic Drug substances

Process Development Highlights

  • Rapid chemical process development and route optimization, with an emphasis on SafeBridge process safety
  • Experience and expertise to overcome process bottlenecks and facilitate process improvements
  • Process development focus on yields, scalability, safety, limited environmental impact, and customer’s program economics
  • Process scale-up and validation support
  • Small scale SMB development
  • Lab-scale non-cGMP custom synthesis

Analytical Development Highlights

Pfanstiehl has a staff dedicated to analytical method development and validation:

  • Assay/release specification development
  • Impurity profiling
  • Structural analysis
  • Reference standard qualification
  • Cleaning method development and validation
  • Elemental impurities and endotoxin method development and validation
  • ICH stability testing protocol development
  • Impurity marker characterization

Kilo Lab Manufacturing

Pfanstiehl has a multipurpose kilo lab containment facility on site including:

  • Carlisle glove box synthesis isolator – Hastelloy C filter and contained tray drying
  • 100 liter glass reactor in Howorth full containment fume booth
  • 100 liter Hastelloy C hydrogenation reactor (50 psi)
  • Broad processing temperature range – (-)80ºC to (+)200ºC
  • Certified to handle compounds down to 0.10 ug/m³ – SafeBridge Category 4 capable
  • Kilo-scale non-cGMP custom synthesis

Pilot and Commercial Scale Manufacturing

Pfanstiehl is equipped with:

  • Large Scale High Potency Manufacturing – Class 100,000 / SafeBridge Category 1-3 production facility
  • Multiple glass-lined 300 gallon reactor trains, with a total primary reactor capacity of 1,500 gallons
  • Flexible cGMP plant can produce up to ~100 Kg lots of potent / cytotoxic drugs
  • New 0.4 m² Hastelloy C Nutsche filter dryer with containment glove box isolator, as well as a multitude of portable Aurora filters (Hastelloy C and Stainless Steel)
  • Contained potent compound milling

Established Commercial Generic APIs

Current API product mix provided to market for over 30 years.