Regensburg, Germany

Our Regensburg site provides API development services and small scale API manufacturing. 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 include:

  • 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.