Friday, February 6, 2015

What is the importance of disposable membrane chromatography systems for mAb purification?

Biopharmaceutical Development and Production Week speaker Siddhartha Shrivastava, Ph.D., Senior Scientist, Downstream Process Development, Patheon recently took some time to sit down with us and discuss his upcoming presentation centered around downstream processing.  Today, he shares  the importance of disposable membrane chromatography systems for mAb purification.

What is the importance of this work?
Sid: Well, the topic as name suggest --- the non-chromatographic platform for mAb purification. As we can see, around 70-75% of those therapies in the market are based on antibodies and the classical way in which industry approaches (this is) to purify them is a bed chromatography approach. What that means is that you need to have a good platform of bed chromatography columns with some costly resins. Of course, we need to have a lot more space, a big footprint resulting in high capital expenditure, as well as operational expenditures for those platforms to purify the mAb.
It is good for a product which has got a long shelf-life or is high in demand, but for the products which have got a low demand or are only for therapeutic or clinical use or clinical trials, that kind of expenditure does not make sense. So, we are trying to focus that part, the drugs which have got a low demand and the product that needs fast turnover, we are trying to develop the technology which will be, in essence, a disposable or single-use so that we would have low validation cost, low cleaning cost and low installation cost and of course, what that would mean are low leading times on the material process that would, of course, mean the product cost would be reduced significantly. 
So, this is the essence and the target of the work that we did. Here at Patheon we are trying to generate a uniform platform matter for the mAB purification using this technique. This will be described in my presentation, as well.
In this interview Dr. Shrivastava also discusses disposable technology, it's cost effectiveness, and how it applies to the large scale.  Download the entire interview here.


Dr. Shrivastava will be presenting Disposable Membrane Chromatography Systems as a Platform for mAb Purification on Thursday, April 2 at Biopharmaceutical Development and Production Week.  As a reader of this blog,when you register to join us March 30-April 2, 2015, you can save 20% off standard rates when you mention code XB15155BLOGJP! Have any questions? Reach out to me at jpereira@iirusa.com.


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