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Downstream Processing

What is downstream processing?

Downstream processing is the recovery and purification of biosynthetic products from natural sources, including animal or plant sources. It is a crucial stage in the production of biopharmaceuticals, chemicals, and other products derived from biological sources. Downstream processing is also used to manufacture polysaccharides, oligonucleotides, and various vaccines.

Downstream processing generally refers to the operations that occur after the completion of cell growth and expansion, drug substance synthesis, or other product formation that falls under upstream processing. Downstream processing aims to isolate, purify, and concentrate the previously synthesized drug substance (or other product) from the complex bulk matrix. Downstream processing may also include formulation activities that help transition a drug substance to a drug product.

These processing activities are performed at pilot, laboratory, and manufacturing scales and involve Manufacturing Science and Technology (MSAT) and Process Analytical Technology (PAT) teams.

How does downstream processing improve healthcare?

Downstream processing is a part of the drug manufacturing process that focuses on harvesting, isolating, purifying, and concentrating the drug substance to create a drug product. It is an essential step in the production of any biological product, and it plays a critical role in ensuring the safety, efficacy, and quality of the final product. It is also the final step in the biomanufacturing process before final formulation and packaging.