One of the biggest challenges facing biomanufacturers is that innovations in upstream processing - the ability to grow cultures at higher densities or new high yield cell lines - have not been matched by downstream processing techs according to Jonathan Robinson from the UK National Biologics Manufacturing Centre (NBMC).
He told BioPharma-Reporter.com that: “Clarification of product streams in downstream processing is a problem. Filters tend to blind quickly and need replacing frequently. This is costly, time consuming and can risk the product. Yields in upstream processes have increased and this has impacted on downstream processing.”
The clarification challenge has created a gap in the market that Merck Millipore – a division of German drugmaker Merck KGaA – hopes it can fill with its new range of Clarisolve depth filters, which were launched in Boston, US earlier this week.
Jennifer Dekarski, Merck Millipore’s product manager for clarification techs, told BioPharma-Reporter.com the filters are designed to improve the clarification of feed streams that have been pretreated which - while better for traditional filters - can still be a challenge.
“Pretreatment technologies are being employed to address these issues but traditional depth filters are not well suited to handle the particle size distribution of these retreated streams which leads to premature clogging.
“The Clarisolve filters are specifically tuned to the particle size distribution of various pre-treatment technologies and are available in 20MS, 40MS, and 60HX configurations” said Dekarski, adding that this approach offers manufacturers cost saving opportunities.
“Using this technology enables customers using pre-treated feed streams to perform single stage clarification - eliminating the need for secondary clarification and centrifugation which results in significant capital savings and also enables a fully single use downstream process.”
Meck has also developed a cationic flocculation reagent - pDADMAC (poly diallyldimenthyl ammonium chloride) – designed to be used with the new filters, however they are compatible with other pretreatments as Dekarski explained.
“The Clarisolve filters work with the pDADMAC reagent recently available, as well as other commercially available acid precipitation and cationic polymers that are used in the biopharmaceutical industry.”