Multiplexing for Efficient Product Development

Susan Dana Jones is a Vice President and Principal Consultant with BioProcess Technology Consultants. She has been in the biotechnology industry for over 25 years, and has been working with BTC for over 13 years. Susan has worked both in the discovery and the early development areas, specialising in cell line development, early process development and the transition of those activities into prodution of early-stage clinical material.

We sat down to talk to her about multiplexing for efficient product development at BPI West 2016.

How can overlapping discovery with early stage development reduce risk?

SDJ: So one of the emerging paradigms in the industry is the tendency for discovery and development to actually be interacting with each other, and this is new. It used to be discovery would run through a screening funnel, come up with one candidate and handed over to development. The change is that there’s communication between the two functions such that the discovery function is given input from development to enable them to pick lead molecules that have better properties and that are easier to manufacture, and that are more stable in solution. In the long run, this will benefit patients who will be getting better molecules that are more stable.

What is the cost impact of a multiplex approach?

SDJ: The multiplexing or bringing multiple candidates across from discovery into the early development activities is a great way to reduce the risk of development because it allows you to actually start testing your molecules in early development activities in cell line development. There is a cost of that however. There’s a cost to each of the early development activities for a single molecule, and when you multiply that by bringing two, three, five or six candidates into those early activities there’s an increased cost. I have seen companies willing to make that expenditure understanding that it will give them better molecules and reduce the risk. There have been a number of talks here at BPI West Conference focusing on that very concept, that bringing multiple candidates and early development activities decreases risk, improves manufacturability and really on the long run saves time, but in the short run it doesn’t save time or money.

What are the key benefits to investors, and patients?

SDJ: So a key benefit to investors in patients of a multiplexing approach and bringing multiple candidates forward in the long run the key benefit is you have better molecules you have better cost of goods you have more stable goods so that they will have a longer shelf life. That gives you more flexibility when a product is commercialised both the manufacturing and the distribution of the storage in the hospital or in the patient setting, and it benefits the patients by having again better more stable molecules.

How receptive are people / companies to expanding traditional views of “development”?

SDJ: Some companies don’t want to try the integrated approach, but it is emerging paradigm. There have been a number of companies presenting that very paradigm. Large companies, small companies and virtual companies are adapting it. The roadblocks are certainly financial. Smaller companies that are not as well financed may not be able to take multiple candidates forward, or they’re institutional large companies where they really have very different divisions of the discovery function and development function maybe even a different location are less likely to be able to efficiently make that transition from the traditional silo approach to the more integrated and multiplex approach.

What technologies enable integration of discovery and development?

SDJ: So there have been numerous technological advances over the last decade or two decades that have improved development first of all. We have ways of imaging cell lines so we can see when we have a

monoclonal cell line, we have micro bio reactors such as the test member system that allows you to test cell clones and then cell culture conditions in very micro scale, but mimicking what you would do in large scale. We have on the downstream side miniaturisation and robots that allow you to do more

screening of more column conditions rapidly to develop the processes. Those advances which were made by development groups to facilitate development and shorten those timelines have also enabled multiplexing approach because it allows you again to bring more candidates forward, get them through some of the early activities, and come out with the process and a product that is superior.

 

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