How Outsourcing Can Accelerate Early CMC Development - How much to spend on early development, whether to use your CMO's proprietary cell line, and other outsourcing advice. - BioPharm International


How Outsourcing Can Accelerate Early CMC Development
How much to spend on early development, whether to use your CMO's proprietary cell line, and other outsourcing advice.

BioPharm International
Volume 23, Issue 7

MILLER: And if you choose to use a proprietary expression system at the early stages, are you then committed to using that system all the way through?

JONES: Yes, because ideally if you can develop a cell line at the very beginning that will take you through to commercialization, you are better off. It is one of the things that is the most difficult to change. If you can get your cell line right the first time, it will mean significant cost savings in the later stages of your development program. So you should choose a system that you are going to stick with.

MILLER: How about when it comes to bioreactor technologies on the market today—flexible bag-based systems that use a lot of disposables. Are there pros and cons of using those systems versus traditional tank-based systems?

JONES: Especially in a CMO, which is by definition a multiproduct facility, there are significant benefits to using disposable systems, eliminating the need to do the cleaning between batches of different products. At the later stages, as you reach larger scales, it's less important as you get to more and more batches of the same product. A lot of companies are using disposable seed reactors for the smaller volumes that are needed before you inoculate the large final production reactor.

MILLER: A big question for a lot of companies is where can they find cost savings in the manufacturing process, and where they should spend money to make sure they get a good outcome.

JONES: At the beginning I said the cell line is very important; it is the crown jewel, something that regulatory authorities look very closely at. It is worth spending the money to get your production cell line right. During process development in the early stages, you can spend as much or as little as you want. If you spend more to get more information about your process, the better armed you are for the later stages. But to get to the clinic quickly, you can implement platform processes for well-characterized classes of molecules such as antibodies. Or you could spend less time; you have to meet safety requirements, but you can spend a lot less money on process development early on.

MILLER: In your experience, what are some of the most biggest mistakes that biopharmaceutical companies make in dealing with a CMO?

JONES: One of the biggest problems is not having the understanding of what your molecule is supposed to look like—not having the analytical methods in place and not understanding what you are asking the CMO to make, and also not having methods that you can transfer to the CMO. I have actually seen projects delayed because analytical methods weren't in place in the hands of the quality control group, and they couldn't do the production run. Another mistake working with CMOs is throwing the process over the fence and waiting for the results to come back. You need to manage the CMO and work with them. You are a team and you are working together on your product, but they are providing the resources. So you need to work together.

This interview has been edited for length and clarity.

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