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Upstream Processing

What is upstream processing?

Upstream processing is the initial stage in drug development in which cells or microbes are grown from mammalian or bacterial cell lines in bioreactors. While it is the first stage, it still impacts the final product’s quantity, quality, and efficiency.

Upstream processing aims to optimize the microbial or cell culture’s growth and productivity while ensuring quality and purity. Many factors may be controlled during upstream processing, including pH, temperature, nutrient supply, and dissolved oxygen. Control of these factors is paramount for ensuring optimal protein expression and cell growth.

There are three steps in upstream processing:

  • Media preparation: Formulating the media composition to support the growth and propagation of the desired microorganisms or cells.
  • Inoculation: Introducing microorganisms or cells into the prepared media.
  • Cell or microbial culture: Incubating the culture vessel under controlled pH, temperature, and aeration conditions. The microorganisms or cells are then grown or multiplied.

Why is upstream processing important?

Upstream processing is necessary because it sets the foundation for downstream processing, which is when a drug substance is purified and formulated into a drug product. However, the final product’s quality and quantity depend on the upstream process’s efficiency and quality.

Because of this, having an optimized upstream process is crucial for producing cost-effective, high-quality, and life-saving products.