The purpose of the downstream process is to isolate and purify the target molecules. Depending on the nature and complexity of the target molecule the downstream process has a significant impact on the overall costs of a drug. It also influences their compatibility and potential side effects. The optimization of the process in the pilot phase ensures a safe and commercially successful production process.
After a first filtration process, cell culture or fermentation broth are stored in the receiver tank for further purification of the target molecules.
Virus Inactivation is an important process step to keep the viruses in a non-infective form in the media. There are 4 main technologies established to achieve this goal: Pasteurization, Solvent- or Detergent-, UV-C- and Low pH treatment. Lowering the pH value is an easy and fast method to treat even large volumes.
Cells and debris are removed in the centrifuge in order to prepare the solution for further purification in downstream processing.
Protein solutions are transferred to buffer systems appropriate for further downstream processing. The buffer systems need to be prepared and controlled carefully in order to obtain excellent purification results.
Chromatography is a workhorse in the separation of ions and charged molecules, i.e. proteins, nucleotides and amino acids. It's a major purification step in isolating target molecules. Depending on the type of target molecule anion-exchange and / or cation exchange chromatography is used.
Prior to fomulation and filling the final product needs to be kept under perfect storage conditions.
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