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
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
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