With a manufactured object, you can often inspect the finished item and judge its quality. With a biologic, much of what matters is invisible in the final product. You cannot look at a vial and determine how the donor was screened or how the material was handled three weeks ago.
What source determines
- What the material actually is. Cells from different tissues behave differently.
- What can legitimately be said about it. Regulatory status follows from what something is and how it was prepared.
- How it must be handled. Requirements are set by the material and the process.
- Whether questions can be answered later. If sourcing is not documented, later questions have no answer.
Consent and screening
Human biological material requires informed donor consent and appropriate screening. This is both an ethical requirement and a safety one. A supplier who cannot describe their consent and screening processes is telling you something important.
Why “we get it from a good supplier” is not an answer
Every link in a chain is a place where information can be lost. If a product passes through several hands and nobody can describe the original source, then the chain has already failed — even if everyone in it was well-intentioned.