Disposable (or single-use) processing provides a number of benefits, such as elimination or reduction of cleaning and cleaning validation; reduction of cross-contamination risk; less operator error; and minimization of capital expenditures and space requirements. Each of these advantages benefit drug companies differently. For example, biotech start-ups are seeking to avoid capital costs associated with hard-piped systems, while the use of disposables helps contract manufacturers eliminate cross-contamination.
Ion-exchange membrane chromatography allows biomolecules to access all binding sites by direct fluid convection. Because the binding is not diffusion limited, high dynamic binding and sharp breakthrough curves are achieved over a wide range of flowrates and molecular sizes. By contrast, resin chromatography is limited due to the speed with which large molecules diffuse through the pore structure of the media. Capital investments in hard-piped columns, coupled with the recurring expense of resins, column packing, cleaning, and cleaning validation make this chromatography method very costly when compared to membrane capsules.
MULTI-COMPONENT ASSEMBLIES Disposable technologies are available for virtually every aspect of biopharmaceutical manufacturing and can be bundled into pre-assembled, pre-sterilized systems. The benefits of disposable processing multiply as single-use technologies expand from stand-alone devices to multi-component assemblies.
Multi-component disposable systems are used for filtration, clarification, purification, and separation applications for numerous vaccines, monoclonal antibodies, and other therapies. Disposable components used in these systems include wide-ranging configurations of direct flow filtration (DFF) filters, tangential flow filtration (TFF) cassettes, chromatography membrane capsules, depth filters, aseptic connection devices, tubing, adaptors, clamps, and bags. These systems can be supplied pre-sterilized (by gamma irradiation) and pre-assembled to eliminate the need for sterilization and sterilization validation procedures. This reduces maintenance costs of sterilization equipment as well as time and labor associated with validation documentation. These bundled solutions can literally be taken out of the box and placed onto the manufacturing floor, reducing the potential for cross-contamination and operator exposure to hazardous biological materials.