cGMP DOWNSTREAM PURIFICATION

The recovery and purification of biologic products is often complex, involving several steps, each with its own challenges for maintaining product integrity—yield, purity and elimination of impurities. Our downstream purification (DSP) cGMP team has the expertise and experience to implement and execute purification processes according to the specifications established during development.

Our state-of-the-art cGMP facility, with dedicated non-live processing areas, was designed to have the flexibility to meet the requirements of your DSP process at various production scales, ranging from milligrams to kilograms.

Our team has expertise in the following areas:

  • Purifying from a wide variety of source material including the following:
    • Mammalian cell culture
    • Plasma
    • Transgenic
  • cGMP downstream purification using the following methods:
    • Column chromatography
      • Ion exchange
      • Affinity
      • Hydrophobic interaction
      • Mixed mode
      • Size exclusion
      • Reverse phase
      • Normal phase
    • Membrane separation
    • Precipitation and extraction
    • Tangential flow filtration (TFF)
    • Ultrafiltration/diafiltration (UF/DF) at scales up to 100 m2 of membrane
    • Virus inactivation and removal through low pH, solvent/detergent, nanofiltration, pasteurization and chemical inactivation
  • Protein modification including the following:
    • Conjugation
    • Refolding
    • Enzymatic conversion