Improve the challenging clarification stepsDuring the last few years, process development efforts have lead to cell culture productivity increase up to titers superior than 1g/l. As a consequence, the early downstream processing steps are becoming more and more challenging and may sometimes appear to be the bottle neck.
Depth filters are commonly used for the primary or secondary clarification and have streamlined the clarification step. However, format limitations persist, heavy housing domes require cranes/hoists, pre-use flushing and CIP use excessive fluids and CIP validation work is time consuming.
As a solution, Millipore has developed an innovative concept of modular, disposable and perfectly scalable clarification tool in order to meet users' expectations around improvement of safety, flexibility, ease of use and economics.
An innovative solutionMillipore’s Pod platform consists of an expandable holder and modular filters that overcome many operational limitations of traditional stainless steel housings. Developed as a self-contained device, each Pod is a single-use filter that reduces the need for clean-in-place (CIP) procedures. This minimizes costs associated with water usage, cleaning and validation. The design not only protects operators from exposure to process fluids, but also allows the units to be drained before change-out for lighter devices that are easier to move. In addition, the design and construction of the Pods can reduce hold-up volume from 40 - 73% over typical configurations of lenticular discs, providing an increase in product yield.
Scalability and flexibilityThe modular Pod platform delivers process scalability and flexibility. The Pod filters are available in three sizes: 0.1, 0.5 and 1m². 4 different media grades of Millistak+® HC can be selected based upon the specific process particle loading requirements and the downstream filter protected : direct harvesting, perfusion bioreactor fluid, post centrifuge or post TFF filtration.
The modular format allows multiple pods to be combined to create the ideal solution to meet any process volume requirement. Two holders are currently available: the Pilot scale holder can accommodate from a single 0.1 m2 Pod filter to five times 1m2 Pods.
The process scale holder expands to hold from five to thirty times 1m2 Pod filters.
Without changing hardware, the system can be run in serial or parallel configurations, combining 2 different grades of filtration in one single operation, to meet specific process and batch size requirements of 20 to 12,000 liters.
The small footprint saves valuable floor space and the lightweight design eliminates the need for hoists or high ceiling heights. In addition, the holder is on casters for easy assembly and movement.
In the age of time to market imperative, the new Pod platform addresses most of Biopharmaceutical industry expectations where speed, quality and economics are the key for success.
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