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Novel single-use tangential flow filtration capsules for downstream bioprocessingIn this Spotlight on Single Use, David Beattie, Vice President BioProcessing R&D, Merck explains the mode of operation and benefits of its Pellicon® Capsules.

What new single-use processing device is your company offering?Merck offers Pellicon® Capsules: novel single-use tangential flow filtration (TFF) devices engineered for ease-of-use, process flexibility and improved product and operator safety in manufacturing monoclonal antibodies, antibody-drug conjugates and other biologics. These efficient, spiral-wound TFF filters perform like Pellicon® cassettes, complementing our many products and services related to TFF and ensuring the quality, availability and safety of life-enhancing drugs.

What distinguishes your device from those of your competitors? Our Pellicon® Capsule is first of its kind. Its holderless design simplifies installation and enables post-use containment for safe removal. The capsules are provided gamma-sterilised and with preservative-free water for reduced preparation time. These features facilitate setup, minimise risk, save time and conserve resources.

What are the main benefits of the Pellicon® single-use capsule for TFF systems?The chief benefits are speed, flexibility, process economics and safety.

■ Plug-and-playThe holderless design simplifies connection to a single-use system by reducing installation efforts and operator errors that may cause integrity failures. Encapsulation enables a closed, disposableflow path for post-use containment with easy, safe device removal and reduced risk of operator exposure and product cross-contamination.

■ Ready to use in minutes The gamma-sterilised filter eliminates pre-use sanitisation. The capsules are supplied in preservative-free,

reverse-osmosis water, which reduces flushing volumes. Time and fluid savings improve batch turnaround and process economics.

■ Proven performance and scalabilityPellicon® Capsules offer the highperformance and linear scalability ofPellicon® cassettes. Capsules have thesame robust, regenerated celluloseUltracel® composite membrane foroptimum product recovery and aturbulence-promoter feed channelscreen that provides high mass transferand flux for superior performance.

When implementing a single-use capsule for tangential flow filtration, what factors should be considered?Ultrafiltration is often the last crucial bioprocessing step; biomanufacturers require final purity. End users of single-use capsules for TFF require proven, scalable filtration products from a reliable manufacturer that first must secure the quality of their drug substance, and also offer efficiencies to accelerate processing speed.

How can the Pellicon® single-use TFF filter affect capital and start-up costs of designing and commissioning a new manufacturing facility?Pellicon® Capsules’ manufacturing benefits include: improved batch turnaround, process flexibility and operator safety with reduced capital costs. The efficient design reduces installation efforts and simplifies operation, requiring minimal preparation and conserving time and resources associated with cleaning and validation. Reduced water and caustics use, utility costs, equipment downtime and unproductive labour save resources and footprint. Improved batch turnaround enhances facility throughput to cost-effectively increase speed to market.

Do manufacturers need to replace all stainless technology to take advantage of the benefits of single-use systems?No, manufacturers can apply single-use technology incrementally. Pellicon® Capsules are simple to integrate into existing facilities without major investments in new equipment. The linearly scalable capsules facilitate transitioning from cassettes, easing process development and validation for current Pellicon® product users. Once manufacturers experience the benefits of single-use bioprocessing, they often look to use it more. Our technical experts can answer questions about applying single-use systems to streamline processes.

What are your sustainability practices? We recognise that every product has environmental impact and engage in life cycle analysis to minimise it. Pellicon® Capsules have substantially lower energy and water requirements than reusable TFF filters, eliminating the need for extensive cleaning and sanitisation between batches. They also reduce operator and environmental exposure to toxic chemicals.

COMPANY DETAILSNAME: MerckADDRESS: Frankfurter Strasse 250, Darmstadt, 64293, GermanyWEB: www.MerckMillipore.comSOCIAL MEDIA: Facebook, Instagram, LinkedIn and Twitter

SPOT LIGHT ON. . . | S INGLE USE

EXPLORESIMPLICITY The Pellicon® Capsule single-use tangential flow filter is uniquely engineered for rapid processing of antibody-drug conjugates and monoclonal antibodies. Made with Ultracel® Membrane technology, the Pellicon® Capsule supports fast, user-friendly installation with no holder and no sanitization required — reducing the risk of product cross-contamination and operator exposure while improving process uptime.

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Pellicon® Capsule

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