Application Note

Scale-up And Tech Transfer From 100 L SIP/CIP Vessel To The 300 L S.U.F.

Source: Thermo Fisher Scientific

By Jason D Brown, Engineer III, Systems Design and Nephi Jones, Senior Manager, Research and Development, Thermo Fisher Scientific

Tech Transfer

With proven expertise and process knowledge, we effectively support product demonstrations in the field. A collaborative study with a new customer was undertaken with the objective of taking an existing, smaller preclinical E. coli process previously performed in stainless steel vessels and scaling it up quickly using the Thermo Scientific™ HyPerforma™ 300 L Single-Use Fermentor (S.U.F.) The following were key objectives for the study:

  1. Demonstrate equivalent growth and product yield at a larger scale.
  2. Identify any process steps or parameters that must be changed to accommodate tech transfer using single-use products.
  3. Demonstrate that various online analytics, such as pH, dissolved oxygen (DO), mass, foam, and mass spectrometer (MS) off-gas analysis, can be beneficial to workflows for disposables.
  4. Demonstrate that expanded data quality may improve outcomes and success in the decision-making process.