Critical process knowledge often exists only in operators' heads—the nuances and undocumented tricks that ensure success. Systematically capturing this 'tribal knowledge' during tech transfer is crucial for preventing hard-to-diagnose failures at the new site.
The build vs. outsource decision is strategic. Building in-house is justified when manufacturing is a core competitive advantage or the process itself is your key IP. Otherwise, outsourcing to a CDMO offers critical speed to clinic and preserves capital.
Seemingly technical roadblocks during tech transfer, like an uncooperative QC manager, often mask underlying human issues like burnout or being understaffed. Addressing the human need (e.g., for predictability) is the fastest way to solve the technical bottleneck.
A leader's time is finite. Maximum value is created not by controlling everything, but by ruthlessly delegating the 80% of tasks others can do. This frees you to focus on the 20% of high-impact, strategic work that only you can perform.
Identical processes and equipment can yield different results due to subtle, often overlooked environmental factors like light exposure, room temperature fluctuations, or vibrations. Tech transfer success requires documenting and investigating these non-obvious variables.