Opinion Former Article

Innovative purifier removes host cell DNA and proteins in bioprocessing applications

Innovative single-use anionic-exchange/membrane hybrid device now available for Laboratory and Scale-up applications to protect Protein A column, enhance yield, and simplify downstream process.

Bracknell, UK, 3 November 2014 – Diversified technology company 3M has announced availability of a unique single-use platform that removes host cell DNA (HcDNA) and proteins (HCP) in various applications within the bioprocessing industry. The new Emphaze AEX Hybrid Purifier from 3M is available as Laboratory and Scale-up capsules. Production capsules will be introduced at the end of the year.

Emphaze AEX Hybrid Purifiers combine six 3M technologies – including, among others, advanced polymers, membranes, non-woven fibres and surface modification – from its repertoire of 46 technology platforms. Emphaze is a hybrid device which integrates both an Anionic EXchange (AEX) media and a downstream 0.2µm highly asymmetric membrane in a single device. The result is a compact design that prevents both cellular debris and soluble impurities reaching the expensive protein-A chromatography column downstream. Emphaze AEX Hybrid Purifers not only improve column-A performance in terms of product purity but also extend column life and integrity by allowing less aggressive cleaning procedures and chemicals. The cleaning regimen is known to have a major effect on column-A capacity fade.

The multi-mechanism AEX media is an all-synthetic Q-functional media that provides well defined low level extractables. Its cationic Q-functional chemistry reduces host cell DNA by 4 Log Reduction Value (LRV) or greater and Host Cell Protein (HCP) load by 25-35 per cent, while also exhibiting very low non-specific protein binding for high yield of therapeutic proteins.

The integrated downstream 0.2 µm membrane reduces Brevundimonas diminuta by more than 6 LRV significantly lowering the risk of bacterial contamination compared to conventional technologies used at the primary recovery stage of the bioprocess. The hybrid purifier also ensures superior clarification; it can be deployed in harvest/centrate feeds of ≤100 NTUs (Nephelometric Turbidity Units) to achieve a clarified solution of <5 NTU, while providing protection for downstream 0.1µm or 0.2µm sterilising membranes and chromatographic stages. This allows the production platform to be designed with smaller sterilising filters, smaller chromatography columns and/or increased column life cycles.

In addition to improving efficiency and protecting more expensive process equipment, Emphaze AEX Hybrid Purifiers are easy to use, scalable and offer reproducible performance. Unlike conventional chromatographic stages there is no need for column packing, negating risk. The range is fully disposable, eliminating the need for cleaning validation, and can be retrofitted into existing 3M hardware platforms.

For more information about Emphaze AEX Hybrid Purifiers, please visit www.3M.co.uk/filtration.

3M and Emphaze are trademarks of 3M Company.

About 3M

3M captures the spark of new ideas and transforms them into thousands of ingenious products.

Our culture of creative collaboration inspires a never-ending stream of powerful technologies that make life better. 3M is the innovation company that never stops inventing. With $31 billion in sales, 3M employs 89,000 people worldwide and has operations in more than 70 countries.

The UK and Ireland is home to one of the largest 3M subsidiaries outside the USA, employing 3,000 people across 17 locations, including nine manufacturing sites.

Products manufactured in the UK include coated abrasives, personal safety equipment, adhesive tapes, industrial microbiology products, drug delivery systems, high-performance coatings, secure documents, passport readers and imaging systems.

For more information, visit www.3M.co.uk or follow @3M_UK on Twitter.


Press contacts:

Amit Karpe                                         Beky Cann

3M Purification Division                 Neesham Public Relations

Tel: +44 (0) 1344 858645                Tel: +44 (0) 1296 628180

Email: akarpe@mmm.com           Email: bekyc@neesham.co.uk

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