3P Biopharmaceuticals´ analytical quality control services support successful development of Biologics from proof of concept to commercial phase.

The quality control department gains experience in transferring analytical methods and have a structured process for assay qualification and validation.

Microbiological QC

Total protein (BCA, Bradford).

ELISA.

Western Blot.

Electrophoresis SDS-PAGE.

Electrophoresis in agarose gels.

Physicochemical QC

  • High Pressure Liquid Chromatography (HPLC): UV, Visible and Fluorencent detection.
  • IR spectroscopy (ATR).
  • UV-VIS.
  • TOC (Total Organic Carbon).
  • pH.
  • Conductivity.

Cellular banks:

  • Purity
  • Viabilty
  • Protein expression analysis
  • Study of plasmid restriction map

Microorganisms counting in nonsterile products

(bioburden).

Endotoxins (LAL).

Mycoplasma detection in cellular culture.

Bacterial strains identification.

Other Services

  • Analytic Methods Transference.
  • Analytic methods validation following guides (ICH, EMA and FDA).
  • Stability studies (ICH).