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.
Jul 01, 2010
Volume 23, Issue 7

Don Farrall/Getty Images
Using contract manufacturers and contract research organizations (CMOs and CROs) is a well-established part of any development program. In this interview, recorded live at the 2010 BIO convention in Chicago in May, Jim Miller, president of PharmSource Information Services, and Susan Dana Jones, vice president and senior consultant at BioProcess Technology Consultants, discuss how biopharmaceutical companies can use CMOs and CROs more effectively. Below are excerpts from the conversation.

MILLER: At what point in the development process should companies be looking for a CMO to work with them on their early-stage CMC requirements?

JONES: You might want to start looking for a CMO before you have identified your lead compound. There are some companies that will help you identify your lead compound and tell you which one has the best qualities to move forward into manufacturing. Otherwise, when you have identified your lead compound, you should already be thinking about how to manufacture it and at what scale, and what your needs are going to be for early clinical trials, and go from there to figure out which CMO you want to work with.

MILLER: Does that mean you really need to have some experience in developing a drug or work with somebody who can advise you on what decisions to make and when?

JONES: It's certainly helpful to have advisors who have knowledge about drug development. A lot of new products are coming out of academic laboratories, where there is less experience in drug development. They should look earlier for development help and get CMOs involved as early as possible.

MILLER: When you go out to look for a CMO, what kind of information should you have in hand that you can bring to them, so that they can evaluate your requirements?

JONES: Obviously you should know what your compound is and what you are trying to manufacture, and anything you know about its performance characteristics. For example, is glycosylation important, so it needs to be in a mammalian system? Is it small and can you make it in a microbial system? Anything you know about what the product is going to end up looking like is very important.

MILLER: What characteristics should a biopharmaceutical company look for when it is choosing a CMO?

JONES: There are different types of CMOs out there with different service offerings. It depends really on what your resources are, what your risk tolerance is, and what your long-term strategy is. If you have the resources, you may choose a CMO that can take you all the way through commercialization, that has full quality and compliance systems, and larger bioreactors. Maybe you prefer to go with a smaller, high-quality, earlier-stage CMO that's not going to get you all the way through, and plan to do a technology transfer later to a larger organization for late-stage and commercialization. There are a variety of other attributes that you should consider, including location. One of the most important things is identifying a team of people you can work with, so that when you meet them, the interactions are good and you know you can develop a process with them.

MILLER: Many CMOs these days are offering proprietary expression systems with the promise that those systems have been optimized and can get you into the clinic more quickly, and can give you much better yields sooner than if you have to develop an expression system from scratch. What's your feeling about the tradeoff between proprietary systems and individually developed systems?

JONES: It's true that there are a number of proprietary expression systems, both mammalian and microbial, and that you will pay some kind of license fee, access fee, or royalty for, but that can give you much higher expression so you can run fewer batches earlier on. That will lead to significant cost savings and give you better cost of goods in the later stages when you commercialize the product. If you have the time and don't need as much product and don't want to pay for it, then there are systems out there that have been off patent and that also can be accessed. I certainly believe there are benefits of proprietary expression systems but I believe they are not for everybody.

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