Teams hyper-focus on replicating process parameters during tech transfer, but this is a blind spot. The true measure of success is a statistically powerful analytical and sampling plan that rigorously proves the process transferred successfully and can detect any deviations.
A CDMO that promises a problem-free process without asking tough questions is a red flag. The best partners are those who challenge your assumptions early. This indicates they are engaged and invested in success, rather than being overconfident or apathetic.
Scaling up a bioprocess from lab to production fundamentally alters physical properties like oxygen transfer (KLA). This change in physics, not necessarily a procedural mistake, is often the root cause of failure at scale, leading to different cell growth and product quality.
Companies often mistakenly expect their CDMO to fill strategic gaps. A CDMO's role is to execute the plan provided. Handing over an incomplete process is a 'wish,' not a tech transfer, and forces them to improvise in ways that may not align with your regulatory or commercial goals.