Article | February 17, 2021

Irvine To Lenexa Site Comparability Study: Dry Powder Media Manufacturing Process

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We have added a new Dry Powder Media (DPM) manufacturing facility to the existing Irvine, Scotland liquid media manufacturing site. The expansion of dry powder milling and blending capability to the facility completes a 5-year Capital Expansion Plan initiated as part of its long-term commitment to supporting customers in the growing industrial biopharmaceutical market. This purpose-built facility will produce animal component free (ACF) cell culture media to provide service to the European and Asian markets and is a redundant manufacturing to the sister facility in North America in Lenexa, Kansas.

Supplementary to the validation work, a Comparability Study (case study) was conducted to demonstrate site-to-site manufacturing comparability assessing media product for the following:

  • Chemical composition
  • Physical properties of milled powder
  • Product performance

The Comparability Study was performed to demonstrate the manufacturing processes and equipment used to produce cell culture media at the Irvine, Scotland (Irvine) site are comparable to those used to produce media product at the Lenexa, Kansas (Lenexa) site. The Irvine facility was designed and constructed with either identical or comparable equipment to the Lenexa facility. To minimize extraneous variability in the study, two media lots (Line 1 each Irvine and Lenexa) were evaluated using the following study conditions:

  • Single product formulation
  • Identical batch size
  • Identical raw material lots
  • Identical sampling and testing
  • Testing performed using same laboratories

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