[Podcast] Disposable Membrane Chromatography Systems for mAb Purification

While around 75% of therapies in the market are based on antibodies and the classical way of purifying them in the bed chromatography approach. This method of purification is only good for a product with a long shelf-life or is in high demand. What about the products with low demand or are only for therapeutic and clinical use?

Siddhartha Shrivastava, Ph.D., Senior Scientist, Downstream Process Development, Patheon says “if the product has got a long shelf-life, a long demand, that makes sense for us to invest in it and create a good infrastructure, a good footprint and bear the high operational and capital expenditure. But, if the product is in the development phase and you need to have some quick lots of drugs so that we can try clinically, that does not make sense. And, by moving to the disposable technology we are also reducing the chances of cross contamination.”

In this podcast interview, Dr. Siddhartha Shrivastava explains:

• The importance of disposable membrane chromatography systems for mAb purification
• Why disposable technology is more appealing compared to conventional technology
• The cost effectiveness of disposable technology
• Large scale testing of disposable membrane chromatography systems

Listen to the podcast or download a transcript here!

Editor’s note: Interested in learning more about the importance of disposable membrane chromatography systems for mAb purification? Then join us for BPI West, March 14-17th in Oakland, CA.

Download the event agenda or visit the event website.

Save $400 - Register with the code BPIWEST16BL

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Has disposable technology been tested on a large scale yet?

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.


Has disposable technology been tested on a large scale yet at Patheon? 

As I said, there are two parts. One is the clarification and we are testing Clarasolve Filters and  he second part is we are replacing chromatographic columns with membranes. So, for our process --- in essence, we are not reinventing the wheel because Clarasolve Filters are from Millipore and the membranes that we are using are from Natrix, one of our collaborators. 

So, we have not reinvented the wheel. What we have done is we have merged both these technologies to come up with a hybrid process which is far more effective and far cheaper compared to the classical platform or traditional platform methods. 

Having said that, we have not yet tested the full process at scale. But, Clarasolve has been using multiple commercial products and they are being used multiple times successfully both by Patheon and by many other companies, as well. And Natrik members are also employed in many of the clinical trials. So, individual contributors are already being tested and are proven in the market that they are liable to be used for the production of human injectibles. We have mix them to produce the whole process and, of course, --- as you know, Patheon is a CDMO and we have got ample opportunities to test them and we are in the process of testing them. But, of course, they are not yet tested at scale.

In this interview Dr. Shrivastava also discusses disposable technology, why it's more appealing than traditional technology and it's cost effectiveness, .  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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How much more cost effective is a disposal technology approach?

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 sheds light on the cost effectiveness of disposable technology.


How much more cost effective is this approach?

Sid: To answer this question I would like to explain the mAb or the industrial standard of gold standard of antibody purification. So, of course, as I said that requires a full battery of chromatographic columns that would be paired with the expensive resins. Among those expensive resins, the major resins which are used for antibody purification is Protein A, which is super expensive. So, that can be a significant. A 100 liter column would run upwards of around $1.6 to $2.5 million dollars. So, it is super expensive and the whole process costs millions of dollars. But, in the approach that we are going to present, you will see that we have replaced these expensive chromatographic columns with our collaborator company Natrix’s, hydrogel membranes, which has reduced the cost significantly. 

And we have also change the classical centrifugation approach to purify the harvest material or the depth filtration material with high capacity new material from Millipore called: “Clarasolve filters”. With the combination of these two systems, we have seen and we have estimated that there would be a significant savings in cost that would run upwards of millions of dollars in whole process. There is a significant chances that this process is very lucrative and very appealing and is also working very nicely.

In this interview Dr. Shrivastava also discusses the appeal of disposable technology 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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Why is disposable technology more appealing compared to conventional technology?

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 looks at the appeal of disposable technology.

Why is disposable technology more appealing compared to conventional technology?
Continuing from where I left off in my last sentence, as I said if the product has got a long shelf-life, a long demand, that makes sense for us to invest in it and create a good infrastructure, a good footprint and bear the high operational and capital expenditure. But, if the product is in the development phase and you need to have some quick lots of drugs so that we can try clinically, that does not make sense. And, by moving to the disposable technology we are also reducing the chances of cross contamination.

As I said before, again, cleaning, and associated cleaning validation, basically reduced maintenance costs, reduced lead times, increased speed of implementation and time to market , that can be significantly be reduced because we have reduced significantly the time of the processing over the 30 some processes. And we have also reduced the labor costs because of the low cleaning requirement or cleaning validation requirement. And, of course, low space requirement and footprint requirement. That is a main reason why disposable technology is more appealing and more and more people want to go towards that.

In this interview Dr. Shrivastava also discusses disposable membrane chromatography systems, 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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Brochure Now Available: IBC's Single-Use Applications for Biopharmaceutical Manufacturing

The full brochure for IBC's 11th Annual Single-Use Applications for Biopharmaceutical Manufacturing meeting, taking place June 9-10, 2014 in Boston, MA.

Join 250 industry and academic professionals this June for THE premiere event on applying disposable technology; an interactive conference geared to make your single-use platforms more efficient, economical and meet more complex drug product demands. Reserve your seat today and hear how industry leaders are implementing today's most efficient single-use systems in order to reduce costs and increase productivity.

· Overcome Complex Drug Product and Manufacturing Challenges
Optimize your time to market by learning about the latest successful applications of single-use technologies that have revolutionized process development and manufacturing

· Streamline Compliance and Influence Harmonization
Hear status updates and interact with representatives from influential standards organizations - BPSA, ASTM, ISPE, PDA, BPOG and ASME BPE - on current harmonization initiatives to assess, reduce and control particulates

· Increase Productivity and Cost Efficiencies
Mitigate risk and ensure reliability by learning how industry leaders are effectively strengthening their strategic manufacturing core philosophies with single-use technology

2014 Keynote Speakers Help You Overcome Complex Drug Product and Manufacturing Challenges

Challenges of Implementing Disposables for Commercial Manufacturing
Dr. Ying Gao, Process Analytical & Development Group, Development & Production, Public Health England

Busting Single-Use System Urban Legends
Robert Repetto, M.S., MBA, Research Fellow, External Affairs, Pfizer, Inc.

To learn more, view our full agenda.

Register with priority code XB14187BLOG to save 20% off of our standard rate. If you have questions about the event, feel free to contact our group manager, Kate Devery (Kdevery@iirusa.com), or visit our webpage.

We look forward to seeing you June 9-10 in Boston!

Cheers,
The Single-Use Team

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