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. Author manuscript; available in PMC: 2020 Sep 7.
Published in final edited form as: Biologicals. 2019 Apr 30;59:68–71. doi: 10.1016/j.biologicals.2019.03.007

Table 2.

Resources investment patterns in late development/commercial activity of biologics product development.

Case Mfg. Processa QC assaysb Bioassay Licensable Mfg. Plantc
A Early Early Early & Late Early & Late (if needed)
B Critical Elements Only Early; All Late Critical Elements Only Early; All Late Critical Elements Only Early; All Late Late (if needed)
C Minimal early; Late criticald Minimal Early; Late Minimal Early; Late Late
a

Need to describe the key elements of a manufacturing process: raw materials, flow charts, process controls.

b

Need to spell out intent of QC assays: assays for purity, potency, identity, physical state.

c

Need to articulate what it takes to license a Mfg. plant: flow diagram, product, personnel, equipment waste & airflow, HVAC & computer system.

d

Focus on selection of appropriate raw materials, vectors and cell source to avoid critical problems at a later stage.