Introducing Planova™ - Assurance Beyond Expectation
World Leader, Launched in 1989
Launched in 1989, Planova™ ﬁlters are the ﬁrst ﬁlters developed speciﬁcally for removing viruses from biotherapeutic drug products such as biopharmaceuticals and plasma derivatives. Planova™ ﬁlters have two decades of proven safety and reliability in the international biopharmaceutical industry. To meet increasing demand, Asahi Kasei Medical Co., Ltd., one of the leading ﬁlter manufacturers continues to expand its Planova™ ﬁlter production capacity.
Robust Virus Removal and Easy Scalability
Planova™ ﬁlters oﬀer an excellent combination of high protein yield, validated virus safety, and scalability. Virus removability is based on size exclusion and depth ﬁltration mechanisms: viruses larger than the mean pore size become trapped. Planova™ ﬁlters are available in pore sizes to match the virus removal needs of particular product applications. The same format housing, combined with the scaled number of hollow ﬁbers in each size ﬁlter, results in a reliable scalability from development work on to large scale manufacturing.
Principles of Planova™ Filter Operation
Planova™ Virus Removal
Planova™ filters contain a bundle of straw-shaped hollow fibers. When a protein solution with possible viral contamination is introduced into the inside of these hollow fibers, the solution penetrates the fiber wall, through a tortuous, three-dimensional network of interconnected void and capillary pores, to the outside. The hollow fiber wall’s dense pore structure is several tens of micrometers thick, resulting in high-capacity virus removal. Viruses are captured gradually and effectively, while proteins migrate outward with minimal adsorption or inactivation.
Planova™ LRV (logarithmic reduction value) rises in proportion to the size of the virus. Planova™ virus removal works on the principle of size exclusion, relatively unaffected by physical or chemical effects, such as adsorption. Therefore, even unknown viruses can be excluded as long as the virus size meets the exclusion specification of the filter.
Wide Rage of Surface Areas with Excellent Scalability
The same format housing, combined with the scaled number of hollow fibers in each size filter, results in a reliable scalability from development work on to large scale manufacturing. Planova™ 15N, 20N and 35N filters are offered in 0.001 m2, 0.01 m2, 0.12 m2, 0.3 m2, 1.0 m2 and 4.0 m2 sizes. The 4.0 m2 filter reduces the number of filters needed for a manufacturing cycle and shortens cumulative integrity test time. The PVDF media Planova™ BioEX filter is offered in 0.0003 m2, 0.001 m2, 0.01 m2, 0.1 m2, 1.0 m2 and 4.0 m2 sizes.
Planova™ BioEX Filters
PVDF Hollow Fiber Filter Construction
The Planova™ BioEX ﬁlter membrane is made of hydrophilized polyvinylidene ﬂuoride (PVDF), a robust material with a unique structure that permits high-ﬂow-rate ﬁltration of high-concentration protein solutions, while maintaining capacity for virus removal. This makes it highly suitable for large-volume production of biotherapeutic products. Planova™ BioEX filters achieve high flow rates with reliable virus removal, thanks to a dense and homogeneous PVDF membrane produced by thermally induced phase separation. The PVDF membrane is made hydrophilic by graft polymerization. Planova™ hollow fiber technology assures high quality consistency and provides outstanding scalability for biotherapeutic manufacturing.
High LRV for Parvoviruses and Larger Viruses
Planova™ BioEX filters are able to remove parvoviruses, which are among the smallest known viruses found in nature, achieving levels below the detection threshold. Planova™ BioEX filters are validated to deliver > 4.0 logs of removal for PPV. For high productivity, this performance is sustained even for large-volume filtration of high-concentration solutions. Extensive testing of Planova™ BioEX filters validates performance for large viruses as well. For example, BioEX achieves > 5.5 logs for A-MuLV.
Laboratory-Scale and Process-Scale
In addition to the process-scale 4.0 m2 and 1.0 m2 Planova™ BioEX ﬁlter, the laboratory-scale 0.001 m2 ﬁlter is oﬀered for developing biological drug product manufacturing processes. Its smaller membrane surface area is convenient for scaled-down qualiﬁcation or validation studies. Additional Planova™ BioEX filter sizes, including 0.0003 m2, 0.01 m2 and 0.1 m2, are available.
Standard Clamp Connections and SIP Capability
For easy integration into manufacturing processes, Planova™ BioEX 4.0 m2, 1.0 m2 and 0.1 m2 ﬁlters are designed for standard sanitary connections. Membrane material and cartridge elements are constructed with the strength and integrity to withstand steam-in-place (SIP) operations.
Planova™ 15N, 20N, 35 N, 75N
Cuprammonium Regenerated Cellulose
The Planova™ 15N, 20N, 35N and 75N ﬁlters are made of cuprammonium-regenerated cellulose hollow ﬁbers. They oﬀer a choice of four mean pore sizes: 15 nm, 19 nm, 35 nm and 72 nm, respectively. Planova™ ﬁlters work on the size exclusion principle and can be applied to a broad range of biologicals, including human plasma-derived proteins and recombinant proteins, especially monoclonal antibodies.
Naturally Hydrophilic Material Maximizes Protein Recovery
Cellulose is the most hydrophilic filter material in use. This natural property of cellulose maximizes the yield of protein recovery by minimizing protein adsorption.
In addition, cellulose maintains high output over long filtration times and is minimally affected by detergent.
Drug Master Files
Filters in the Planova™ line are individually identified and supplied with a Certificate of Analysis. Drug Master Files are on file with the US FDA for Planova™ 15N, 20N, 35N and 75N filters.
The Planova™ 75N filter is designed to remove impurities or aggregated proteins prior to final virus filtration. It is available in 0.001 m2, 0.01 m2, 0.3 m2 and 1.0 m2 sizes.