Pall introduced what it claims is the first disposable depth filter capsule for pilot through to large-scale biotech drug manufacturing, which ties in with the company's vision of a completely disposable production facility.
Biopharmaceutical companies increasingly adopt disposable processing solutions to reduce validation bottlenecks, contamination risks and cost, according to the company.
The SUPRAclean depth filter capsule is intended for use in clarification and prefiltration of biological solutions used to manufacture recombinant protein-based drugs, vaccines and blood products, and should save time, labour and operating costs compared to clean in place filter units.
It is estimated that the capital costs of setting up a unit using disposable materials are 30 per cent less than a traditional, stainless steel facility, and there are dramatic time and labour savings from not having to clean and sterilise the process unit - and validate that it is truly aseptic - between runs.
Other benefits can include less down-time, enhanced process security, greater process flexibility and the greater speed-to-market for new products.
Meanwhile, Millipore, which is also pushing the disposable factory concept, has introduced a new triple layer prefilter range that should extend the life of final filters in biopharmaceutical manufacturing applications, particularly those based on cell culture.
The company says the Polysep II media offers high retention, flow rate and throughput and provides a good prefiltration performance for processes using sterilising-grade membranes in aqueous-based filtering applications.
The products "combine the dirt-holding capacity of a depth filter with the retention efficiency of a membrane filter,"according to the company. They are made of borosilicate glass media and two cellulosic membranes, with the range extending from bench top to full-scale manufacturing capabilities.
Polysep II is currently available in cartridge filters, and disposable capsules (Opticap XL and XLT), and will be added to Millipore's OptiScale range of small scale filtration devices later this year.
The total world market for filtration products used in biopharmaceuticals applications is approximately $4 billion a year.