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Downstream Development

Downstream Process Development

Our main goal is to establish robust and economical downstream processes on lab scale, scale-up to pilot and production levels. The quality of the API (active pharmaceutical ingredient) plays an essential role for its activity and safety with respect to future clinical trials. On this account we consider individual needs of the API for the selection of suitable purification methods to maintain its structural and functional parameters, while removing all potential contaminants like host cell proteins, DNA and endotoxins.

Therefore we apply different techniques like filtration (cell removal, dia-/ultra-filtration, virus filtration etc.), affinity-, ion exchange-, size exclusion-, hydrophobic interaction, multi modal chromatography and membrane adsorption technologies, only to name a few. We constantly strive to incorporate new and up to date methods and techniques to expand and improve our portfolio.

We already start the downstream process development during cell line development, as soon as first material is available. This integration of cell line and process development enables the early development of analytical methods and helps to save time in the later stages of process development. Our experienced scientists cover all the methods of protein purification. A wide spectrum of analytical methods is already applied for product characterization and in-process controls during downstream process development.

The following main steps are included for the development of an optimal downstream process:

  • Testing of scalable chromatographic techniques
  • Analytical development
  • Control of impurity removal
  • Optimization of DSP steps
  • Definition of holding steps
  • Establishment of a GMP compliant DSP
  • Implementation of virus removing/inactivation steps
  • Validation by an external virus safety study
  • Process scale-up and consistency
  • Pre-formulation study

Once the process is completed it can then be transferred to our separate GMP unit.