Tech Transfer: A Tremendous Opportunity

Looking at the timeline of a typical tech transfer event (Figure 1) gives us a different perspective on their impact. Everything on the right half of the timeline is repeated cycles that happen when you perform additional tech transfers, such as internal transfers from other parts of your organization to a separate site around the world. But the CQAs in process development and the process recipe cycle ultimately need to get built into your regulatory filings. The groups within your organization working on those areas will need that information to prove that your recipes really work. Ultimately, because you don’t have that single version of the truth, it impacts your ability to perform effective tech transfer, process validation, site-to-site comparisons and many other critical actions in the most efficient way.