QC is responsible for the sampling, testing and analyzing of a range of diverse test articles including starting materials, stability samples, in-process samples, final product and environmental monitoring samples.  QC also plays an active role in the setting of specifications and the organization, documentation and release of products.  This ensures that the necessary and relevant tests are carried out, and that materials are not released for use until their quality has been judged satisfactory.

The Quality Control department (QC) of SynCo Bio Partners is part of Quality Affairs and is independent from the Manufacturing department.. The QC department holds a GCLP licence (N° 102157 EL), allowing QC to serve as a contract laboratory for third parties.

SynCo's QC department has two main divisions: Analytical Chemistry/Biochemistry, and Microbiology/Environmental Monitoring:

• Analytical chemistry is involved with the non-protein related analyses for quality control. This includes starting materials, active ingredients, in-process samples, final products and stability testing. Available methods include:
  • ultra/high performance liquid chromatography (UPLC/HPLC)
  • ion chromatography
  • gas chromatography
  • IR and UV / Vis spectroscopy
  • fluorimetry
  • total organic carbon (TOC)
  • (Karl Fisher) tetrimetry
  • tapped density
  • thermal analysis (DSC, TGA)
  • pH, conductivity and more.....
• Analytical biochemistry involves quantification and identification of proteins and peptides for in-process and final product samples. For these analyses the following methods are available:
  • Threshold
  • HPLC
  • FPLC
  • SDS-PAGE (reduced, non-reduced)
  • UV / Vis spectrophotometry
  • fluorimetry
  • amino-acid analysis
• Microbiology involves microbial analysis for quality control of starting materials, active ingredients, in-process samples, final products and MCB/WCB stability testing. Available methods are:
  • microbial adventitious agents testing
  • phenotypic testing
  • microbial limit testing
  • sterility testing
  • endotoxin testing
  • identification of isolates (VITEK)
  • viability testing and closure integrity testing.
• Environmental monitoring is performed to assess the microbiological quality in the classified areas of the production facility. Environmental monitoring is performed using general microbiological techniques.