CDMO services: what is cdmo scope in practice, how cdmo companies differ, and what to ask cdmos before a technology transfer

What to establish before committing

1. Separate development from manufacture. Ask which of the two the organisation is genuinely built for, and look at where its senior technical people sit. A development-strong provider will discuss your molecule's problems; a manufacturing-strong one will discuss slots, changeover and batch records. Both are valuable and you probably need them at different times.
2. Capacity and the slot. Manufacturing capacity is booked ahead and slots are the real currency. Establish what is actually reserved, what happens if your programme slips, and what happens if theirs does. A slot with no contractual consequence on either side is a statement of intent.
3. Technology transfer is the risky interval. Most failures happen when a process moves between sites. Ask how transfer is run, who leads it, what documentation accompanies it and how comparability is demonstrated at the receiving site. A provider with a written transfer protocol has done this before.
4. The quality system and inspection history. Ask which regulatory authorities have inspected the site, when, and the general outcome, and ask to see the site's approach to deviations and change control. A provider reluctant to discuss its inspection history is telling you something.
5. Analytics: theirs, yours or both. Decide whether methods transfer to the provider, stay with you, or are developed by them, and who owns them afterwards. Analytical method ownership is a recurring source of friction and is far easier to settle at contracting than in the middle of a campaign.

What a CDMO is not

It is not a substitute for your own technical understanding of the process. The provider executes and will follow the process that is agreed, and the organisation that understands why each parameter is set where it is remains yours. Programmes that outsource that understanding lose the ability to judge a deviation.

It is also not a research organisation. A contract research organisation runs studies; a CDMO develops and makes material. Some do both under one roof, and where they do, ask which side the people assigned to you actually come from.

Contracting for the unhappy cases

Write down what happens when a batch fails, who pays, and who owns the investigation. Write down what happens when the timeline slips on either side. These clauses are the ones that get read, and negotiating them at signature is far cheaper than negotiating them during a failure.

Settle ownership of the process, the cell bank, the analytical methods and any improvement made along the way. Providers often ask for broad rights to process improvements, which can matter later.

Common questions

What is a CDMO?

A contract development and manufacturing organisation: a provider that develops a manufacturing process for a product and makes material to it under a quality system. Development and manufacture are different capabilities and few providers are equally strong at both.

What is the difference between a CDMO and a CRO?

A contract research organisation runs studies and generates data. A CDMO develops processes and manufactures material. Some organisations offer both, in which case ask which side your assigned team comes from.

What should I check before technology transfer?

That there is a written transfer protocol, a named lead, a documentation package, and an agreed way to demonstrate comparability at the receiving site. Transfer is where most outsourced processes go wrong.

Who owns the analytical methods?

Whatever the contract says, so settle it at signature. Method ownership, along with the cell bank and process improvements, is a recurring source of dispute once a programme is under way.

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