Pharmaceutical API CDMO Services

Vice President of Research & Development, Dr. Trevor Calkins, discusses Pfanstiehl’s API CDMO philosophy and capabilities at the CPhI/InformEx exhibition in Philadelphia.
Pfanstiehl offers a wide array of API development services at its campus just north of Chicago. The company has the first ever Safebridge Certified facility in the world, is passionate about solving complex chemistry challenges, and is focused on being in lockstep with clients from early preclinical through commercialization.

Key Technology Areas of Focus – cGMP

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

Process Development to Commercialization

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

cGMP Synthesis Experience

Vast experience in a wide array of synthesis.

Process Development Highlights

Rapid chemical process development and route optimization, with an emphasis on SafeBridge process safety.

Analytical Development Highlights

Dedicated staff for analytical method development and validation.

Kilo Lab Manufacturing

On site multipurpose kilo lab containment facility.

Pilot and Commercial Scale Manufacturing

Large scale potency manufacturing – Class 100,000 / SafeBridge Category 1-3 production facility.

Established Commercial Generic APIs

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