Quality Control

The Quality Control (QC) department of SynCo is part of Quality Affairs and is independent from the Manufacturing department. The QC department holds a GCLP license (license number: 102157 EL), which means that QC can serve as a contract laboratory for third parties. 

QC is responsible for sampling and testing a wide range of materials including raw materials, in-process samples, drug substance samples, drug product samples, stability samples and environmental monitoring samples. SynCo’s personnel are trained in state-of-the-art analytical techniques. The instruments SynCo employs are validated according to current guidelines (including ICH) and the methods of analysis meet all international requirements and will be qualified/validated for the specific product development stage.  

SynCo's QC department has two main divisions: Analytical (Bio)chemistry, and Microbiology: 

Analytical (Bio)chemistry is involved in raw material testing, in-process control testing, bulk drug substance testing, drug product testing and stability testing. For these analyses the following equipment is available:

  • RP HPLC with UV (dual wavelength and diode array), fluorescence and refractive index detection
  • SEC HPLC with UV (dual wavelength and diode array) or UV-RI-MALLS detection
  • IEX HPLC with UV (dual wavelength and diode array) detection
  • UPLC
  • FPLC
  • Ion Chromatography (conductivity (CD), pulsed amperometric (PAD) and diode array (UV/VIS) detection)
  • Gas Chromatography (GC) (packed and capillary, split-splitless, headspace and gas injections, FID and TCD detectors)
  • SDS-PAGE (reduced, non-reduced) (Coommassie/Silverstain/Western blot)
  • ELISA
  • Residual DNA (Picogreen)
  • Total protein: Bradford/Lowry/µBCA/QBCA
  • Residual moisture (Karl Fischer)
  • Osmolality
  • Conductivity
  • pH
  • Extractable volume
  • Spectrophotometric analysis (microplate and UV/VIS)
  • FTIR, IR, Fluorescence and UV/Vis/spectroscopy
  • Total organic carbon (TOC) (NPOC and TC/IC)
  • Amino acid analysis
  • Tapped density
  • Thermal analysis (DSC, TGA)

Microbiology is involved in microbial analysis of raw materials, in-process samples, bulk drug substance samples, drug product samples, stability samples and environmental monitoring. Available methods are:

  • Microbial adventitious agents testing
  • Phenotypic testing
  • Microbial limit testing
  • Sterility testing
  • Endotoxin testing
  • Microbial identification (VITEK/API)
  • Growth promotion testing
  • Viability testing and closure integrity testing 

For specific analyses which are not offered by SynCo, SynCo works with approved subcontractors.

Services