The ongoing Interphex show in New York has seen continued evidence of the expansion of disposable technologies into areas of bioprocessing currently dominated by multi-use items, reports Phil Taylor.
Yesterday, Pall contributed to the trend by unveiling a new single-use chromatography capsule - the Mustang XT5000 - that takes membrane chromatography into territory formerly dominated by conventional column chromatography, such as capture and large-scale polishing filtrations. The company said the product 'brings manufacturers one step closer to realising completely disposable manufacturing processes'.
To date, Pall's Mustang range of membrane chromatography capsules have been used for applications such as removal of contaminants (DNA, viruses, endotoxins and host cell proteins) at the 100 or 1,000 litre scale. But limitations on the volumes that can be handled by the capsules have prevented their use in other applications - such as large-scale polishing at the 10,000 litre scale or capture filtrations at the 1,000 litre scale - so column chromatography has been used.
However, column chromatography has a number of drawbacks. One is its low flow rate, which can make these filtration steps take several hours to complete, and another is the requirement for the resin used to be cleaned, regenerated, and validated, which adds to the time and cost of the procedure.
Now, Pall has developed a capsule that can handle five times the volume of its largest membrane capsule to date. The Mustang XT5000 has a volume of 5 litres and a flow rate of 50 litres/minute - compared to 8 litres/min for a 50 litre column chromatography setup.
This translates to significant time savings, according to Pall. Holly Haughney, vice president of Pall Life Sciences, presented case study data showing that a 1,000 litre process volume could be conducted in 50 minutes with the membrane capsule, versus eight hours with the column, mainly because it removes the need for media packing and wash, regeneration and cleaning steps.
Moreover, the membrane capsule achieved significant cost-savings. For example, the latter process used 1,150 fewer litres of buffer, which carries the not inconsiderable cost of around $4 per litre, factoring in handling, storage and disposal costs. This $4,600 saving, plus around $550 saved in labour costs, yields an overall cost saving per run of $5,150.
It also reduces the risk of over-running into two shifts, which can play havoc with production schedules, she noted, and as a disposable item brings the additional benefit of reducing the risk of cross contamination.
The Mustang XT5000 capacity allows Pall to leapfrog nearest rival Sartorius - which offers a rival product which tops out at 2l capacity - into first place, according to John Jenco, who led the technical team behind the new product.
He told In-PharmaTechnologist.com that the capsule is a premium product - coming in at a cost of $15,000 per capsule or around $3,000 per litre compared to $1,000-$2,000 for a column-based system - but that this is more than offset by the economic savings. In addition, he noted that the current version is machined, and its price tag is likely to drop once a version based on moulded components is developed, and of course if sales volumes rise.
"Mustang technology will play a critical role in preventing bottlenecks in process chromatography steps as macromolecule drugs move from clinical trials to pilot and full-scale production," said Dr Haughney.
The Mustang XT5000 can be configured in series up to three high or manifolded in parallel for use in large volume applications, she said. Pall is also introducing a scale down, 5ml version of the capsule for process development and quality assurance.