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Maintaining Batch-to-Batch Consistency

The biopharmaceutical industry is a multibillion-dollar industry that is rapidly developing into the most promising high-tech pillar industry.

Biopharmaceutical production is a complex and multi-faceted process that encompasses inherent variability. The heterogenous nature of biopharmaceuticals makes them sensitive to subtle changes during manufacturing, processing and storage, that can impact their safety and efficacy in clinical use. Understanding, defining and controlling such product variability is therefore a central challenge for all biopharmaceutical manufacturers.

Although it is difficult to assess the full impact of failure rates, it has been estimated that 7.2% of batches are lost every year. The main source of error during biomanufacturing is batch contamination, which accounts for 2.3%.

Key Essential Learning Objectives:

• Managing the manufacturing process

  A breakdown of the four essential stages 

• What is Batch-to-Batch Consistency?

  Common causes of batch variability

• The idea cell culture environment explained

  The importance of reproducibility during bioprocessing

• Using equipment to ensure reproducibility 

  Where in the biopharmaceutical workflow are lab equipment utilized