Regensburg, Germany Site

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.

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