Single-Use Technology for Monoclonal Antibodies

Single-Use Technology for Monoclonal Antibodies

Shortened Time to Market Drives Process Improvements

Biologic drugs based on monoclonal antibodies (mAbs) have seen a growing number of approved products due to their effectiveness in combating diseases including cancer, auto immune diseases and rheumatoid arthritis. Opportunities for increased production of monoclonal antibodies in turn increases competition within the biopharmaceutical industry. The growing demand and increased competition for these biologic treatments requires even greater efficiencies in R&D and manufacturing.

Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful pathogens such as viruses, like SARS-CoV-2. Like other infectious organisms, SARS-CoV-2 can mutate over time, resulting in genetic variation in the population of circulating viral strains.

Sophisticated monoclonal antibody production systems help drive accelerated times to market to get the therapeutic treatment to the patient. These increasingly complex systems demand process development that support a rapid transition to full scale production. The development and production of mAbs have a major influence on single use bioprocessing systems market growth.

mAb Systems Criteria:

  • Deliver enhanced design flexibility​
  • Adapt quickly to new operating conditions​
  • Able to scale​
  • Easily transferable to various manufacturing facilities​
  • Offer effective handling of media substances​
  • Yield increased cost-effectiveness​
  • Support robust single-system technologies​
  • Support wide variety of bioreactors including microbioreactors, benchtop and production bioreactors

Growing Demand for Single-Use Technology (SUT) in Biopharma

A majority of bioprocessing manufacturing companies depend on single-use systems to develop, produce and get mAbs to the market faster. Additionally, the growing number of monoclonal antibody therapeutic products being developed and produced for the diagnosis and treatment of auto immune disorders, cancer and other infections is furthering the single use bioprocessing market growth. ​

SUT offer a wide range of benefits in pharmaceutical manufacturing:​

  • Enhanced scalability
  • Mitigate contamination risk preventing resource waste and improving yield
  • Higher degree of flexibility process design
  • Ability to fit existing, validated production processes​
  • Significant potential for cutting overall system costs​
  • Increased capacity and prod

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