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