by Oliver Yu
Basically, you enter the virtuous cycle thusly:
- Design an experiment
- Execute the experiment
- Analyze the data for clues
- Go to Step 1.
You're thinking, "Gosh, that looks a lot like Process Sciences (aka Process R&D)." And you'd be right. That's exactly what they do; they run experiments at small scale to figure out something about the process.
Territorial disputes are common when it comes to local Manufacturing Sciences groups having local labs. From the Process Science's perspective, you have these other groups that may be duplicating work, operating outside of your system, basically doing things out of your control. From the Manufacturing Science's perspective, you need a local resource that works on the timetable commercial campaigns to address very specific and targeted issues. People who can sit at a table to update the local plant on findings.
If your cashflow can support it, I recommend developing a local lab and here's why:
The lab counterpart of the Manufacturing Sciences group ran an experiment that definitively proved a physical bioreactor part was the true root cause of poor cell growth... this poor cell growth had delayed licensing of the 400+ million dollar plant by 10 months. The hypothesis was unpopular with the Process Science department at corporate HQ and there was much resistance to testing it. In the end, it was the local lab group that ended the political wrangling and provided the data to put the plant back on the tracks towards FDA licensure.
I do have to say that not everything is adversarial. We received quite a bit of help from Process Sciences when starting up the plant and a lot of our folks hailed from Process Sciences (after all, where do you think we got the know-how?). When new products came to our plant, we liaised with Process Science folk.
My point is: in more cases than not, a local manufacturing sciences group with laboratory capability is crucial to the process support mission.