Millipore has introduced a single-use prefilter for clarification steps in mammalian cell synthesis that continues the trend towards increasing use of disposable technologies in the bioprocessing environment, reports Phil Taylor.
The company launched its new product - known simply as the Pod - at the ongoing Interphex show in New York, US. The new platform consists of an expandable holder and modular filters that provides an alternative to current stacked disc technologies such as Millipore's own Millistak HC product range and, according to the company, improves process speed, safety and economics in the manufacture of biopharmaceuticals.
Stacked discs - introduced earlier this decade - have already provided significant improvements in processing time, but still have significant limitations. For example, operators setting up these systems must lift a heavy stainless steel housing dome - weighing upwards of 40 pounds - using a crane or hoist in order to place or remove filter discs. This places the operator at risk of exposure to process fluids, and means that the filter system needs a lot of space.
Millipore's new system takes the form of a self-contained filter that is stacked horizontally, rather than vertically, but still has a much smaller footprint than an equivalent stacked disc system and is lightweight at around 25 pounds, so it does away with the need for lifting equipment and the high ceilings this demands.
The Pods and feed ports and other fittings are fully disposable, all but removing the need for clean-in-place procedures, and the filters are modular, allowing users to run the filtration in series or parallel, at scales from 10 litres to 12,000 litres, without changing hardware.
In addition, the design and construction of the Pods can reduce hold-up volumes - the amount of liquid required to fill the filter - by 40 to 73 per cent compared to equivalent stacked disc systems. This reduces the amount of water and buffer that needs to be used and hikes product yield, said Charles Lambalot, product manager at Millipore's BioPharmaceutical division.
Meanwhile, the small size of the filter devices mean that there is generally less solid waste to dispose of in comparison to a stacked disc system, and the Pods are designed so that they cannot be installed backwards - something that can occur with a stacked disc system.
Lambalot told In-PharmaTechnologist.com that the Pod will be positioned as a premium product compared to Millistak, but that the higher purchase price - around $9,000-$10,000 for a small holder - is quickly offset by operational cost savings. The smaller footprint is also important as it allows companies to scale up easily as their bioprocess volumes increase, he added.
The Pod system has been beta tested by 21 customers, including vaccine manufacturers, large-scale biotechnology companies and contract manufacturers, and the first system shipment has already gone to a Korean firm, he added. The product is available worldwide, with process and pilot-scale holders and the Pods themselves in inventory.
Susan Vogt, president of Millipore's biopharmaceutical division, said that the industry has been looking for a range of improvements in traditional depth filtration technology, including scaleability, ease-of-use and cleaning and validation requirements. "The self-contained, disposable modular design of our new Pod filter technology addresses these issues," she said.