Table 1.

Process complexity and risk should dictate the intensity of the start-up support

Relative technology transfer complexity	Risk scorea	Support description	In-plant support
Same product, new strain, similar process, same site	0	“Light”	1 person on site for the first run
New product, similar process, same site	1	“Lean”	2–3 people on site. Minimal Debug Plan
New product, modified process, same site	2	“Moderate”	1 person per unit operation. Critical aspects of Debug Plan implemented
New product, modified process, new unit operations or new CMO	3	“Heavy”	1–2 people per new unit operation. Full Debug Plan. Specialized or vendor support on new unit Ops
New product, modified process, new unit operations, new CMOs	4	“Full Court Press”	Two support staff per unit operation. Full Debug lan including parallel fermentations and parallel DSP operations. Specialized or vendor support on new unit Ops

^aRisk increases if the product is new, the process is new, there are new unit operations, and/or the manufacturing site is new