Celebrate Cyber Monday with 25% Off IIR and IBC Pharma and Life Sciences Events

Use code CYBER25 for 25% off the current rate TODAY ONLY. For this exclusive savings use code CYBER25 to register today, November 30th for all the below IIR and IBC Life Sciences pharmaceutical and life sciences conferences:

Antibody Engineering & Therapeutics

December 7-10, 2015

San Diego Convention Center

San Diego, CA

Discount code: CYBER25

Download the brochure: http://bit.ly/1MZnpHL

Register: http://bit.ly/1MZnmf3

RIM

Regulatory Information Management Summit

December 14-15, 2015

Ritz Cartlon

Washington DC

Discount code: CYBER25

Download the brochure: http://bit.ly/1lU3rYj

Register: http://bit.ly/1NinS7j

FDA/CMS Summit

December 14-15, 2015

Washington DC

Discount code: CYBER25

View the agenda: http://bit.ly/1lpMvs8

Register: http://bit.ly/1lpMrIN

Drug Delivery Partnerships
January 20-22, 2015

PGA National Resort & Spa

Palm Beach Gardens, FL

Discount code: CYBER25

Download the brochure: http://bit.ly/1QPkxU0

Register: http://bit.ly/1NDAXye

Asia TIDES

February 24-26, 2016

Westin Miyako Kyoto

Kyoto, Japan

Discount code: CYBER25

Download the brochure: http://bit.ly/1lU53S2

Register: http://bit.ly/1IjGIyR

ePharma

February 29-March 2, 2016

Sheraton Times Square

New York, NY

Discount code: CYBER25

Download the brochure: http://bit.ly/1YD9hLV

Register: http://bit.ly/1YD9gaA

BioProcess International Conference & Exposition West

March 14-17, 2016

Oakland Marriott City Center

Oakland, CA

Discount code: CYBER25

View the preliminary agenda: http://bit.ly/1OzE7A6

Register: http://bit.ly/1HzTgSP

TIDES

May 9-12, 2016

Long Beach Convention Center and Entertainment Center

Long Beach, CA

Discount code: CYBER25

Download the brochure: http://bit.ly/1OqjtEp

Register: http://bit.ly/1HzTwkH

We hope to see you at our 2015-16 events!

*All registrations are subject to approval. Discounts cannot be retroactively applied*

Cheers,

The IIR and IBC Life Sciences Teams

Share this article with your social network, just click below to share now!

Share |

How to improve your monoclonal antibody harvest step using flocculation with smart polymers

In my last post (Might the sun be setting on process-scale chromatography for the purification of biopharmaceuticals?) I discussed how the trend of increasing bioreactor productivity at a near exponential rate has outstripped developments in packed-bed chromatography leading to bottlenecks in downstream processing.

Addressing the need for purification methods with higher throughputs will be the subject of presentations at the BioProcess International 2015 conference, however, seeking ways to eliminate chromatography steps is not necessarily the only solution to the problem of throughput-constraints in purification.  

Flocculation and cell culture harvests

Ken Kang from Eli Lilly and Company is scheduled to present on “Monoclonal flocculation with smart polymers for efficient clarification of high titer cell cultures and improved removal of impurities”. In 2013, Kang and collaborators from both Eli Lilly and Company and EMD Millipore published an article in the journal ‘Biotechnology and Bioengineering, 2013;110:2928-2937’ describing an alternative harvest process for monoclonal antibodies (mAbs) using the stimulus responsive polymer, benzylated poly(allylamine) as a flocculent followed by depth filtration.

Highly productive bioreactor processes also typically generate both high cell densities and levels of impurities that put additional pressure on purification trains. Although a relatively low resolution purification technique, flocculation can be used to remove considerable amounts of cells, host cell proteins and DNA in a quickly and cheaply. This decreases the burden on chromatography columns allowing a reduction in the number of cycles that must be performed and increasing the usable lifetime of resins. An additional benefit is that flocculation process are relatively easy to fit into existing equipment configurations without having to perform a whole-scale redesign of manufacturing facilities.

Residual levels of impurities in Protein A chromatography eluates

The process described in the article was not only high yielding and improved the clearance of cell debris but  also reduced aggregated product, HCP and Nucleic Acids. The burden on polishing chromatography steps was considerably reduced as the investigators were able to show that once the clarified cell culture filtrate was purified by Protein A chromatography the impurities in the eluate were so low they potentially met drug substance requirements. Crucially the team were able to demonstrate the clearance of residual polymer using fluorescence tagging.

Could flocculation improve your antibody harvest step?

The results from studies on flocculation such as this one seem both to present a path forward to reduce the impact of downstream bottlenecks while also being readily implementable. Flocculation processes seem relatively easy to develop, scale and operate without requiring sophisticated or expensive new equipment. What do you see as the benefits and challenges associated with this bioprocessing technique?

About the Author: Dr Nick Hutchinson has a Masters and Doctorate in Biochemical Engineering from University College London, UK where he focused on laboratory tools for rapid bioprocess development and characterization. He then worked at Lonza Biologics in an R&D function investigating novel methods for large-scale antibody purification before moving to an operational role scaling-up and transferring manufacturing processes between Lonza sites in the UK, Spain and USA. Nick now works in Market Development at Parker domnick hunter where his focus is in bringing Parker's strengths in Motion & Control to Bioprocessing. This will enable customers to improve the quality and deliverability of existing and future biopharmaceuticals.

https://uk.linkedin.com/pub/dr-nick-hutchinson/0/b38/37 

Join me at #BPIconf

Share this article with your social network, just click below to share now!

Share |