Downstream Processing

Downstream processing refers to the sequence of operations required to recover and purify a biological product, such as a therapeutic protein or vaccine, following its synthesis in an upstream process like fermentation or cell culture. The primary objective is to isolate the target molecule from the complex mixture of cell debris, culture media, and other contaminants it was produced in. This multi-step process typically involves initial recovery and clarification (e.g., centrifugation, filtration), followed by purification and concentration using techniques like chromatography, and concluding with formulation to ensure the final product has the required purity, stability, and activity for its intended application. As a critical component of bioprocess engineering, downstream processing focuses on designing scalable, efficient, and cost-effective purification schemes that meet stringent quality and safety standards.

  1. Introduction to Downstream Processing
    1. Definition and Scope
      1. Definition of Downstream Processing
        1. Scope within Bioprocessing
          1. Historical Development
            1. Terminology and Nomenclature
            2. Role in the Overall Bioprocess
              1. Integration with Upstream Processing
                1. Impact on Product Quality
                  1. Influence on Process Economics
                    1. Relationship to Formulation and Fill-Finish
                    2. Key Objectives
                      1. Achieving Product Purity
                        1. Maximizing Product Yield
                          1. Ensuring Product Potency
                            1. Enhancing Cost-effectiveness
                              1. Meeting Regulatory Requirements
                                1. Maintaining Product Stability
                                2. Classification of Biological Products
                                  1. Proteins and Peptides
                                    1. Therapeutic Proteins
                                      1. Monoclonal Antibodies
                                        1. Enzymes
                                          1. Hormones
                                            1. Growth Factors
                                            2. Vaccines
                                              1. Live Attenuated Vaccines
                                                1. Inactivated Vaccines
                                                  1. Subunit Vaccines
                                                    1. Viral Vector Vaccines
                                                    2. Nucleic Acids
                                                      1. Plasmid DNA
                                                        1. mRNA
                                                          1. Oligonucleotides
                                                            1. siRNA
                                                            2. Antibiotics
                                                              1. Small Molecule Antibiotics
                                                                1. Peptide Antibiotics
                                                                2. Industrial Enzymes
                                                                  1. Food Processing Enzymes
                                                                    1. Detergent Enzymes
                                                                      1. Biofuel Enzymes
                                                                        1. Textile Enzymes
                                                                        2. Cell and Gene Therapy Products
                                                                          1. Viral Vectors
                                                                            1. Cell Therapies
                                                                          2. Intracellular vs. Extracellular Products
                                                                            1. Characteristics of Intracellular Products
                                                                              1. Characteristics of Extracellular Products
                                                                                1. Implications for Downstream Processing Strategy
                                                                                  1. Product Location and Accessibility