Biopharmaceuticals

Quality control

  • Development and establishment of analytical methods
  • Validation of release-related methods
  • Development and validation of potency assays (e.g. ELISA)
  • Determination of visible particles according to Ph. Eur. 2.9.20
  • Determination of the tightness of rubber stoppers for containers according to Ph. Eur., Chapter 3.2.9 (self-sealing)
  • Spectrophotometric quantification and evaluation of the purity of proteins, DNA / RNA
  • Measurement of protein stability and aggregation (Prometheus NT.48, NanoTemper Technologies GmbH)
  • External order analysis with qualified and audited partner laboratories