Regensburg, Germany

Specilized Capabilities

Specializing in rapid scale up and chemical production of intermediates and APIs for Phase I and Phase II clinical trials under cGMP / ISO conditions, Regensburg’s expert services include:

• Early development manufacturing (batch size typically 1-50 kg)
• Pre-Clinical and Phase I/II development support
• Rapid scale-up from lab to kg
• Chemical process optimization
• Non-GMP and GMP manufacture of APIs (and pre-steps)
• Stability studies
• Analytical method development and validation
• Reference standard syntheses and characterization
• Indicative polymorph studies and salt screenings

Additionally, our Regensburg site has been GMP-Certified by German Authority for the “Manufacturing of APIs for Clinical Trials” since 2008 (last inspection in 2014).

Site Offerings

• Small molecule production (Miniplant)
• Rapid scale up from lab to Miniplant scale (1 – 100 kg range)
• cGMP manufacturing of Phase I / Phase II materials
• Demonstration batches for technical transfer projects to Linz site
• Solid state investigations
• Process implementation and development
• Chemical process optimization
• Process safety studies (ARC, DSC)
• Chemical route scouting projects
• Analytical method development and basic method validations
• Forced degradation and stability studies
• Reference standard synthesis and characterization
• Supporting basic polymorph studies and salt screenings
• Analytical method development and basic method validations
• Reference standard synthesis and characterization

Learn more about the specific equipment and capabilities at this site by downloading our Site Fact Sheet.