Advances in technology are allowing biomanufacturers to move to entirely single-use set-ups for tangential flow filtration and benefit from the many advantages of single-use technology. Tangential flow filtration (TFF) is a common operation in the manufacture of biopharmaceuticals and has traditionally been performed using reusable cross flow filters installed in stainless steel systems. Innovations in single-use technology can bring many benefits to biopharmaceutical TFF operations.
TFF applications in bioprocessing
Tangential flow filtration applications are typically divided into microfiltration or ultrafiltration applications depending on the cut-off of the membrane used. Microfiltration is often used to effect solid-liquid separation, such as the clarification of E.coli lysates or even mammalian cells. Ultrafiltration is more commonly associated with the concentration and diafiltration of soluble biopharmaceutical products, such as recombinant proteins and monoclonal antibodies, either during their purification or at the end of the purification process to prepare the product for filling operations.
Drivers for switching to single-use setups for TFF operations
1. The solutions and steam required for cleaning and sterilizing reusable filters and systems need to be generated by installing dedicated equipment with a capital and running cost.
2. Validation of the steaming and cleaning regimes takes time and delays the speed with which new biopharmaceutical products reach the market.
3. There is a risk of product cross contamination in multi-product facilities because, even if the filters are dedicated to a particular product, the equipment itself is unlikely to be.
4. Stainless steel systems are inflexible and difficult to modify. This is especially a problem during the development of the process when optimum configurations are being identified, but it can also represent a challenge post-approval if continuous improvement activities identify configuration optimization opportunities.
Innovations in technology are now allowing biomanufacturers to switch from stainless steel TFF operations, and their associated challenges, to entirely single-use set-ups.
Innovations in single-use technology
1. Single-use, gamma-irradiatable TFF filters
2. Pilot and 21 CFR Part 11 compliant single-use automated systems
3. Fully disposable fluid flow paths
4. Single-use sensors for measuring critical processing parameters
Single-use automated TFF solutions are fully scaleable from lab to GMP manufacturing and increase flexibility during process development, delivering more optimized processes. With reduced assembly, set-up and tear down time, manufacturing productivity is enhanced while capital investment in utilities, plant and time to market is reduced. Importantly, these benefits can be achieved while increasing quality through minimizing cross contamination risks, delivering a higher level of control and standardizing the operators’ experience.
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This post was contributed by Nick Hutchinson, Market Development Manager (Pharma & Biotech) at Parker domnick hunter Process Filtration, UK.