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Regensburg, Germany

Regensburg, Germany

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

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.