The new Minim II and new Centramate 500 tangential flow filtration (TFF) systems enable laboratories to test ultra-low-solution volumes when determining true scale-up conditions
Testing protein solutions to determine processing conditions for full-scale manufacturing has become very expensive for drug discovery and research laboratories, due to the low available volumes of these solutions in the early stages of the drug life-cycle.
To address the critical need for affordable testing equipment that can reliably process small sample volumes, Pall has launched two new tangential flow filtration (TFF) systems.
The new Minim II and new Centramate 500 TFF systems enable laboratories to test ultra-low-solution volumes when determining true scale-up conditions.
This optimizes processes and reduces development times.
Additionally, the systems provide data-logging to meet increasingly strict regulatory requirements for process design (DQ) validation.
The Minim II system is the industry's first affordable TFF system that performs feasibility and scale-up studies, with data-logging for ultra-low volumes, in a truly reliable and reproducible manner.
As an operating system used in conjunction with cassettes, the benchtop Minim II TFF system is applicable to cell and cell lysate clarification, and concentration and diafiltration applications critical to developing countless biotech drug therapies.
It can be operated at pressures typically associated with large-scale TFF processes, and offers a completely sanitary design necessary to comply with good manufacturing (GMP) standards for calibrated process instrumentation.
The Minim II system's touch-screen operation indicates flow path, pressures and temperatures.
It can be used with up to three Minimate TFF membrane cassettes simultaneously for accurate and quick feasibility and scale-up studies.
When using three cassettes of identical molecular weight cut-offs (MWCO), the unit can operate up to 150cm2 of effective membrane area, accelerating development times.
Cassettes with different MWCOs can also be used simultaneously to select the most appropriate MWCO for a given application.
Testing three different MWCO membranes in a single experimental run can potentially cut development time for this critical selection process by one-third.
For the next stage in drug development, including pilot scale and early clinical trial process optimization, Pall's new Centramate 500 TFF system enables low-volume testing with minimal rinsing and clean-in-place volumes.
The system is ideal for drug discovery applications that are moving to the development cycle, utilizing up to five litre process volumes with the in-built reservoir, and more using external tanks.
It provides an effective membrane area ranging from 200cm2 up to 1m2.
The Centramate 500 system offers a sanitary design that is self-venting and completely drainable.
It is portable with a small footprint and a modular design, and it is suitable for operation in a GMP-qualified environment.
In addition to its benefits for drug development, the Centramate 500 system can be used for scale-down applications at the drug manufacturing stage.
The data-logging functions of both the Minim II and Centramate 500 TFF systems allow users to transfer all data as ASCII files, simplifying reporting for regulatory oversight.
In light of industry trends towards heightened scrutiny of data used early in the drug development cycle, this provides drug manufacturers with the added benefit of verifiable quality assurance.
"In offering vastly improved functionality, these systems offer a cost-effective solution to laboratories of all sizes," says Thomas Scholz, marketing director TFF technologies, Pall Biopharmaceuticals, Pall Life Sciences.
"They also provide a continuum of total fluid management solutions to help drug researchers and manufacturers optimize processes throughout the entire drug development cycle."
