If you ever peeled a hard-boiled egg, you know it doesn’t always come out right.
Sometimes it sticks, leaving behind a patchy egg white and a big mess.
Sometimes it elegantly peels off, leaving a satisfying smooth surface.
And all this before talking about soft-boiled eggs, which are a culture of their own.
In order to find the best way to make a boiled egg, you must first define what you want.
In pharma, we call it the Quality Target Product Profile (or QTPP).
Once we establish the most critical elements of the product that would ensure it works (and is safe)- we can properly invest our efforts in developing the manufacturing process.
When we start the journey, we know very little and use generic knowledge as a starting point (i.e.- an injectable product must be sterile- surprising, right? Don’t worry- if you forget, the regulations will remind you)- but the more we progress with clinical development, the better we know of the nuanced Critical Quality Attributes (CQAs) that impact safety and efficacy, and we do deliberate studies to find what process parameters are critical to maintaining them (You guessed right- they are called CPPs).
So if anyone wants to learn how to make Pharmaceutical grade boiled eggs- start with defining your QTPP…
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