Biotechnology companies are making significant advances in production of higher concentrations of proteins critical to meeting the demand for life-saving therapies
Despite this advance, production bottlenecks remain because standard filtration technologies lack the ability to perform economically at high flow rates in these high concentration solutions.
Working to meet the challenge faced by one of the world's leading biotechnology companies, Pall developed two new filtration technologies that significantly improve production throughput for protein-based biotech drugs.
The new Supor UEKV and new Fluorodyne EX high flow sterilizing grade cartridge filters are each unique hybrids that offer the biotech industry cost-effective solutions to processing challenges.
Sterilizing grade filters are utilized throughout the drug processing cycle from initial purification steps to final formulation and filling to remove bacteria and other contaminants.
The validated and technologically advanced 0.2micron sterilizing grade Supor UEKV filter brings together Pall's proprietary Ultipleat high-efficiency membrane packing technology with a new small-core design that enables a 50% increase in filter membrane area in the same size filter element.
The Supor UEKV filter also incorporates Pall's innovative machV prefilter membrane layer composed of a polyethersulfone (PES) with a multi-dimensional asymmetric pore structure.
This filter construction provides consistent contaminant removal capacities at an exceptionally high processing rate of 17 litres per minute at 100mbar (12lpm/psid).
This flow rate is approximately 35% faster than previous generation filters with conventional pleating and core geometry.
The mach V prefilter layer and extra filter membrane area extends the service life of the filter and reduces replacement costs.
Supor UEKV filters are able to clarify and sterilize cell-containing fermenter harvests and tissue culture media faster than conventional membrane cartridge technology and are compatible with fluids across a wide pH range, from buffers to numerous biological fluids.
Sturdy construction enables the Supor UEKV filter to tolerate up to one bar (14.5psi) of differential pressure during steam-in-place sterilization, making it highly resistant to steam pressure incursions and the filter is easy to wet for reliable integrity testing.
The new Fluorodyne EX filter is also constructed with Pall's Ultipleat design.
It provides an alternative leading-edge hybrid technology by fitting a proprietary built-in mach V PES prefilter membrane layer over a proven high flow 0.2micron polyvinylidinedifluoride (PVDF) sterilizing membrane.
This dual membrane combination also delivers high dirt-holding capacities and high flow rates, as well as the flexibility for steam sterilizing under wet or dry conditions.
The ability to steam sterilizing the filters without pre-wetting reduces preparation time, as a separate wetting step is not required.
The Fluorodyne EX filter technology can be used o sterilize a wide range of fluids including buffers, biological fluids, tissue culture media and ophthalmic products.
The asymmetric built-in prefilter membrane layer enables the Fluorodyne EX filter to process the heightened levels of contaminants often found in high protein biotech solutions, with low protein and preservative binding, and low extractables.
"The biotech industry relies heavily on sterilizing grade filtration, but until now, process membrane filtration technology has not kept pace with advances further upstream," says Monica Cardona, marketing manager, western hemisphere, Pall Life Sciences.
"Pall's new sterilizing membrane filtration technologies are the result of close alignment with our biotech customers to help them maximize efficiency downstream, enabling greater throughput of the high concentration biological products common today."
