Technology news 13

Filtration+Separation November/December 2011

Novasep launches protein A mediaLife sciences specialist Novasep has launched AbSolute High Cap, a new generation protein A media, based on modified silica.

AbSolute High Cap can capture monoclonal and polyclonal antibodies from high titre and large volume feedstock. According to the company, the product can outperform other approaches on the market by 50-200% in a wide range of flow rates.

AbSolute High Cap could enable biopharmaceutical companies to reduce significantly the cost of protein A resins, with potential savings of up to a few million US dollars per year on a commercial scale. The cost of downstream processing is around 70% of the manufacturing cost of mAb with the capture step being the single most costly step, as it uses the very expensive protein A based affinity chromatography resins (media). Currently the market size of protein A resins is

estimated at US$150-200 million, Novasep says.

Because of the improved productivity achieved by using AbSolute High Cap, less resin is required to perform the purification of the same volume of fermentation feedstock. In this way, the Novasep product can lead to a reduction in the cost of goods for monoclonal and polyclonal antibodies. Resin savings are estimated of up to two million dollars per year for large productions (for a 1.5 g/L mAb titre and 20,000 L bioreactors). This is particularly significant for the near term production of biosimilars because the cost of goods is more critical, but it could also be considered by any biotech that needs to scale up the production of their developmental antibodies or significantly reduce their upfront consumables expense, the company advises.

www.novasep.com

3M introduces advanced bio filters3M Purification has launched a range of bioburden reduction filters combining the high filtration performance of membrane-type media with enhanced flow characteristics, enabling lower system costs and longer operating lifetimes.

The new LifeASSURE PNA Filter Series from 3M’s Purification division can be used as pre-filters or final filters, where a high level of microbiological control is required. They are designed specifically for biotechnology, pharmaceutical and biological applications, such as production of vaccines, laboratory fluids, blood products, fine or bulk chemicals, and purified water.

“The advanced technologies we have engineered into the new LifeASSURE PNA Filter Series will enable customers in the bioprocess, pharmaceutical and other sectors to reduce capital costs and operating overheads whilst simultaneously benefiting from improved microbiological control,” said Andrew Whitehouse, sales and marketing manager for 3M‘s Purification division.

LifeASSURE PNA filter assemblies are available with

either a 0.2μm or 0.45μm filtration rating and feature an asymmetric membrane with 3M’s Advanced Pleat Technology (APT) that maximises the useful surface area of the filter. In addition, optimised filter media support layers are positioned upstream and downstream of the membrane. Together, these innovations increase flow rate per unit pressure, allowing designers to meet performance targets using fewer cartridges thereby enabling smaller, lower-cost systems. In continuous operation mode the filters achieve longer service lifetimes, saving the costs associated with frequent filter changes. In batch process applications, the higher flow rate can help reduce the number of filters needed to process a given batch volume.

Moreover, tests confirm superior reduction of microorganisms. The 0.2μm PNA020 membrane provides Log Reduction Values (LRV) in excess of 7 with B. diminuta (ATCC 19146) at a challenge concentration of at least 107cfu/cm2, while the 0.45μm PNA045 filter achieves an LRV greater than 8 for S. marcescens (ATCC 14756) at 106cfu/cm2 or higher.

www.3M.co.uk/filtration

The new LifeASSURE PNA Filter Series from 3M’s Purification division.