cGMP Facilities /

QC Laboratories

QC testing

Biotechpharma´s QC team is highly experienced with a large variety of state-of-the-art analytical methods to perform an in depth-evaluation of the manufactured biopharmaceuticals. This way, our clients are served in the best possible way to have a comprehensive analytical package available to support their regulatory filings. Also most sophisticated analytical techniques can be performed in-house at Biotechpharma, thereby contributing to short development timelines and reducing the need for outsourcing complexity. Our Quality Control state-of-the-art laboratories and Grade A, B, C and D clean rooms for biological and sterility testing are fully equipped and have capabilities to evaluate the quality of the manufactured product by testing its:

  • Identity
  • Potency and quantity
  • Product purity and impurities
  • Process related impurities

Key equipment includes:

  • HPLC (Waters)
  • RT-PCR (Applied Biosystems)
  • Capillary electrophoresis (Beckman Coulter)
  • Absorbance plate reader (Tecan)
  • UV/Vis spectrophotometer (Implen)
  • Analyser of sub-visible particles in liquids (Particle Measuring Systems)
  • Automated cell culture analyzer (Roche)
  • Sterility testing equipment (Millipore)
  • Membrane filtration equipment for bioburden testing (Millipore)
  • Automated titrators (Metrohm)
  • Immunoassays equipment
  • Constant climate chambers for stability studies according ICH (Binder)
  • Environmental monitoring equipment