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A Mab A Case Study In Bioprocess Development -

The Medical Devices Regulation 2017/745/EU (MDR) has new requirements for label of medical devices.

A Mab A Case Study In Bioprocess Development

A Mab A Case Study In Bioprocess Development -

The primary article you are looking for is titled "A-Mab: A Case Study in Bioprocess Development," published on October 30, 2009, by the CMC Biotech Working Group International Society for Pharmaceutical Engineering (ISPE)

The A-Mab study breaks down bioprocessing into distinct, interconnected stages: A Mab A Case Study In Bioprocess Development

Design Space: A key output is the definition of a "design space"—the multidimensional combination of input variables (e.g., temperature, pH, feed rates) and process parameters that have been demonstrated to provide assurance of quality. Bioprocess Development Phases in A-Mab The primary article you are looking for is

  • High productivity (>20 pg/cell/day)
  • Stable expression over 60 days
  • Low levels of impurities (<5%)

3.5 Viral Filtration

  • Filter: Planova 20N (20 nm)
  • LRV: > 4.0 for parvovirus (small, non-enveloped)

The Solution: Bioprocess development isn’t just about "picking the best cell." We optimized the fed-batch culture media. By shifting from a standard glucose feed to a dynamic feeding strategy based on metabolic markers (like lactate and ammonia levels), we reduced metabolic stress on the cells. The result? The cells produced slightly less total protein, but the quality profile was pristine, with aggregation dropping below 1%. but the quality profile was pristine

The primary article you are looking for is titled "A-Mab: A Case Study in Bioprocess Development," published on October 30, 2009, by the CMC Biotech Working Group International Society for Pharmaceutical Engineering (ISPE)

The A-Mab study breaks down bioprocessing into distinct, interconnected stages:

Design Space: A key output is the definition of a "design space"—the multidimensional combination of input variables (e.g., temperature, pH, feed rates) and process parameters that have been demonstrated to provide assurance of quality. Bioprocess Development Phases in A-Mab

  • High productivity (>20 pg/cell/day)
  • Stable expression over 60 days
  • Low levels of impurities (<5%)

3.5 Viral Filtration

  • Filter: Planova 20N (20 nm)
  • LRV: > 4.0 for parvovirus (small, non-enveloped)

The Solution: Bioprocess development isn’t just about "picking the best cell." We optimized the fed-batch culture media. By shifting from a standard glucose feed to a dynamic feeding strategy based on metabolic markers (like lactate and ammonia levels), we reduced metabolic stress on the cells. The result? The cells produced slightly less total protein, but the quality profile was pristine, with aggregation dropping below 1%.