Downstream Purification Development

Passion for your process, product and patients

Preserving the high yield of your protein whether expressed in mammalian or microbial cells through upstream processing or from transgenic or plasma sources requires efficient downstream purification (DSP). Decisions made during the development of your DSP process can significantly affect the reproducibility, scalability and cost-effectiveness of your process.

It is critical that the best materials such as purification resins, media, buffers and filters are selected, used and optimized to meet the specific requirements of the target protein to maximize yield, purity and activity when developing a DSP process.

Our team has extensive experience not only in developing and optimizing processes but also in scaling processes up and transferring them to cGMP manufacturing in our facility. We are passionate about delivering the best possible client experience, and we work closely with you throughout process development taking into consideration time, cost and process performance.

Our expertise in downstream purification allows Therapure Biomanufacturing to develop purification processes using a wide range of methods such as:

  • Column chromatography (resin selection, screening, initial scouting, optimization and scale up) including the following techniques:
    • Ion exchange
    • Affinity
    • Hydrophobic interaction
    • Mixed mode
    • Size exclusion
    • Reverse phase
    • Normal phase
  • Membrane chromatography
  • Precipitation and extraction
  • Tangential flow filtration (TFF), ultrafiltration/diafiltration (UF/DF)
  • Viral inactivation and removal through low pH, solvent/detergent, nanofiltration, pasteurization and chemical inactivation

Additionally, we specialize in the following:

  • Protein modification
    • Conjugation
    • Refolding
    • Enzymatic conversion

We have experience developing bench-scale DSP processes (<1 L) to clinical and commercial scale (100 –1,000 L) for proteins derived from a wide range of sources:

  • Mammalian cell culture
  • Transgenic organisms
  • Plasma
  • Cryoprecipitate
  • Microbial fermentate