| Component | Cost per gram mAb | |-----------|------------------| | Media & feeds | $18 | | Protein A resin (reused 50 cycles) | $12 | | Polishing resins & buffers | $8 | | Filtration (depth, virus, UF) | $7 | | Labor & QC | $15 | | | $60 / g |
These seemingly simple numbers dictate the entire manufacturing strategy. A Mab for subcutaneous injection requires high concentration (≥100 mg/mL) and extremely low viscosity, which immediately rules out certain purification methods and formulation buffers. A Mab A Case Study In Bioprocess Development
The process begins by identifying the antibody's CQAs—physical, chemical, biological, or microbiological properties that must be within an appropriate limit to ensure safety and efficacy. | Component | Cost per gram mAb |
The monoclonal antibody (mAb) in this case study, denoted as mAb-A, targets a specific antigen involved in the progression of a certain type of cancer. The antibody was generated through a combination of immunization, hybridoma technology, and clone selection. With promising preclinical results, the next step was to develop a scalable bioprocess for its production. The monoclonal antibody (mAb) in this case study,
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| Component | Cost per gram mAb | |-----------|------------------| | Media & feeds | $18 | | Protein A resin (reused 50 cycles) | $12 | | Polishing resins & buffers | $8 | | Filtration (depth, virus, UF) | $7 | | Labor & QC | $15 | | | $60 / g |
These seemingly simple numbers dictate the entire manufacturing strategy. A Mab for subcutaneous injection requires high concentration (≥100 mg/mL) and extremely low viscosity, which immediately rules out certain purification methods and formulation buffers.
The process begins by identifying the antibody's CQAs—physical, chemical, biological, or microbiological properties that must be within an appropriate limit to ensure safety and efficacy.
The monoclonal antibody (mAb) in this case study, denoted as mAb-A, targets a specific antigen involved in the progression of a certain type of cancer. The antibody was generated through a combination of immunization, hybridoma technology, and clone selection. With promising preclinical results, the next step was to develop a scalable bioprocess for its production.