In cell and gene therapy, the manufacturing partner is not a vendor. They are frequently the difference between a therapy existing and not existing. Developers know this, which makes them unusually rigorous and unusually anxious buyers.
The search starts from fear
CGT developers approach manufacturing with a specific worry: the expertise they need is scarce, the capacity is constrained, and a failure here can set the program back by a year or kill it outright.
So they search early, they search hard, and they screen ruthlessly for one thing above all others: have you actually made this exact kind of thing before?
Why general capability is worthless here
This is the most specialized manufacturing category in the industry, and general competence does not transfer. A CDMO with excellent monoclonal antibody credentials tells a lentiviral vector developer nothing useful. An AAV specialist is not automatically a CAR-T specialist.
Developers therefore filter on modality-specific, demonstrated experience, and they are unforgiving about it. A profile that claims broad advanced-therapy capability without naming the specific modalities, platforms and processes reads as a company hoping to learn on someone else’s program, which is exactly what no developer will accept.
The four questions they will ask
- Have you made my modality? Specifically, verifiably, with evidence.
- Do you genuinely have capacity, and when? Vague or optimistic answers here are treated as a red flag, because capacity overcommitment is a known industry problem.
- What is your quality and regulatory record in advanced therapies? Regulators scrutinize this space closely, and the developer inherits your problems.
- Can you transfer and scale my process? Technology transfer in CGT is genuinely hard, and a partner who underestimates it is dangerous.
Being findable early matters more here than anywhere
Because capacity is scarce, developers engage manufacturing partners far earlier than in other modalities, often before they would in a conventional program. That means the window in which you can be discovered opens sooner and closes faster.
If you are a specialist with genuine CGT capability and you are not visible when developers start looking, they will fill their slot with someone else, and that slot will not reopen.
Be the company they find
CGT developers are searching for specialist capacity right now, and the slots are finite. Make sure they can find you before someone else fills it.
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Frequently asked questions
How do cell and gene therapy developers choose a manufacturer?
They search early because capacity is scarce, and they screen ruthlessly on modality-specific demonstrated experience. They ask whether you have made their exact modality before, whether you genuinely have capacity and when, what your quality and regulatory record is in advanced therapies, and whether you can transfer and scale their process.
Why is general manufacturing experience not enough in CGT?
Because this is the most specialized manufacturing category in the industry and competence does not transfer across modalities. Excellent monoclonal antibody credentials tell a lentiviral vector developer nothing useful, and an AAV specialist is not automatically a CAR-T specialist. Developers filter unforgivingly on specific, demonstrated modality experience.
When do CGT developers start looking for a manufacturer?
Earlier than in other modalities, because quality capacity has often been in short supply and securing a slot takes time. That means the window in which a manufacturer can be discovered opens sooner and closes faster, so specialists who are not visible when developers begin searching lose the slot to someone else.
