Attention:

Certain features of Sigma-Aldrich.com will be down for maintenance the evening of Friday August 18th starting at 8:00 pm CDT until Saturday August 19th at 12:01 pm CDT.   Please note that you still have telephone and email access to our local offices. We apologize for any inconvenience.

cGMP Manufacturing – SAFC - Buchs

SAFC Buchs, Switzerland specializes in complex, multi-step, organic custom synthesis of intermediates and raw materials from Phase I to Phase III clinical trials. This cGMP, ISO certified site provides a wide range of development and production capabilities, including Simulated Moving Bed (SMB) chromatography and flow chemistry technology.

Working in close alignment with other SAFC global facilities, SAFC Buchs offers its customers the quality, dependability and flexibility to move their products to market quickly and efficiently.

The Complete analytical support for all our cGMP operations from raw material quality control (QC) to final product release

Manufacturing

Buchs offers a broad range of multi-purpose manufacturing capabilities and is a proven contract manufacturing partner that accelerates the development process.

  • Over 30 vessels, up to 1,600 L capacity
  • Temperature range: -65 to +200 °C
  • Three rotary evaporators (50 L)
  • Two distillation stills (100 and 250 L)
  • Two thin-film evaporators
  • Small-scale chiral (SMB) separation unit
  • Flow Chemistry synthesis
  • Biocatalysis

Chemistry Development Services

Buchs chemists are known for their ability to solve chemistry challenges and developing efficient chemical processes that support customers’ programs. Comprehensive development services include:

  • Eight Ph.D. process development chemists
  • Specialized technologies proven to reduce development times
    In situ FTIR reaction monitoring
    – Automated lab reactors
    – Micro-reactor technology
  • Proficiency in scaling-up processes targeted for large-scale manufacturing
  • Process validation support

Analytical Services

The Complete analytical support for all our cGMP operations from raw material quality control (QC) to final product release.

Comprehensive array of analytical capabilities including:

– NMR
– Polarimetry
– KF
– GC
– AAS, ICP-MS
– LCMS
– FT-IR
– ROI
– UV-VIS
– DSC
– GCMS
– CE
– HPLC und UPLC
– Endotoxin
– Bioburden
  • Raw material, intermediate and final product testing methods
  • Impurity identification and characterization
  • Method validation and stability testing

Regulatory Compliance

Our experienced team of regulatory compliance experts have a proven track record of successful DMF submissions and can support:

  • Preparation of regulatory filings (NDAs)
  • Vendor audits
  • Control documentation and testing
  • I CH and cGMP compliance
  • Scientific and technical writing

Project Management

All project managers are integrated into SAFC’s worldwide project management team and serve as the single point of contact for customers.

Project managers are assigned and responsible for all activities, communications and milestones:

  • Work with chemistry team leader, analytical, manufacturing and regulatory affairs
  • Provide weekly summary reports
  • Use Gantt Chart tracking
  • Provide business development support