Pall pushes disposables
biopharmaceutical manufacturing, Pall is following market demands
bolstering its product line by adding a number of disposable
products to its portfolio.
Among the new additions showcased at the recent Interphex trade show in New York, were the company's new disposable biocontainers for the biopharmaceutical industry. The single-use bags for collection and transport of process solutions, product intermediates and cell-culture media form part of Pall's disposable Allegro System for biopharmaceutical manufacturing. With all the advantages of disposable manufacturing components such as reducing time and cost associated with cleaning and validation processes, Pall claims its biocontainers are formed from an advanced film material that reduces extractables and leachables to a very low level. The company made this a specific feature of the product, addressing reservations manufacturers have had regarding wider implementation of disposable technologies. Listening to concerns from customers about existing products also inspired other features of the biocontainers, such as avoiding the 'toothpaste tube' problem of squeezing the last drop from the bag: "We designed our containers for maximum drainability so you don't lose any of the precious protein solution because it's stuck in a corner of the container," Ian Sellick of Pall told US-PharmaTechnologist.com at the Interphex show. "We also deliberately provide an area at the top of the bag for labelling well away from the fluid to avoid contamination risks from solvents in label adhesives." Despite the fact that Pall had the option acquire single-use bag manufacturers, the company opted to develop the product itself in-house instead. As well as filling this particular gap in the company's portfolio, Pall also introduced another product in the form of the industry's first tangential flow filtration (TFF) capsule for single-use biopharmaceutical applications. TFF is used to clarify, concentrate and purify proteins. The Kleenpak TFF Microfiltration Capsule is intended to offer the industry a disposable alternative to traditional steel equipment, offering a high-flux rate with "minimal hold-up volumes" according to the company. "This new product is totally disposable and requires no external hardware to make it work," said Sellick. "This is really quite a dramatic development for the industry, to have a tangential flow device with no hardware at all." The capsule itself is lined with a membrane that provides a large surface area for filtration to increase throughput, as well as boasting very low adsorption characteristics. Available in pore ratings of 0.65µm, 0.45µm and 0.2µm, typical process volumes for the technology are around 200L, but the capsules can be manifolded to allow larger process requirements. A further advantage of Pall's disposable TFF capsule is that it is a self-enclosed unit, reducing potential workplace hazards by limiting exposure to biologically active solutions, in addition to the numerous other advantages reeled out in favour of disposable manufacturing in terms of savings and reduction in contamination risk. Taking the time to investigate what is needed to fill the gaps in the company's portfolio with products that fulfil customer needs seems to be a characteristic of Pall's approach to the new products it introduces. "We felt there were deficiencies in what was currently available," Sellick said of Pall's motivation to develop products in-house. "We'll only do something if we think we can do it much better…We may not necessarily be on the market first with a particular technology, but we spend time trying to ensure that we actually do bring the user some tangible benefit."
