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16 BioPharm International eBook June 2019 Single-Use Systems Buffers "The platform includes four main components, including: buffer dilution system, buffer concentrates, single-use assemblies, and services." —Andrew Bulpin, MilliporeSigma A NEW PLATFORM BioPharm: Can you describe the Bio C ont i nuu m Bu f fer prepa ra- t ion pl at for m a nd wh at c om - prises it? Bulpin: The BioContinuum Buffer Delivery Platform is a first-of-its- kind integrated solution for buffer delivery. It is tailored to provide the highest level of accuracy and precision in buffer preparation and management. This ultimately helps drug manufacturers increase manu- facturing efficiency utilizing a frac- tion of resources and facility space. The platform includes four main components, includ ing: bu f fer dilution system, buffer concen- trates, single-use assemblies, and services (described below): • Buffer concentrates—standard mAb buffer concentrates that are delivered in Mobius assem- blies (customizable single-use assemblies) • Dilution skid—system for on- site, in-line dilution of buffer concentrates as well as standard skid with options • System ser v ices — ser v ices for qualification, validation, train- ing, and maintenance of the buffer dilution system • Mobius assemblies—custom sin- gle-use assemblies for filtration, storage, and on-site transport of diluted buffers. BioPharm: How is single-use tech- nology and/or components incor- p orated i n t he Bio C ont i nuu m Buffer preparation platform? Bulpin: Mobius Select gives users the ability to design configured single-use assemblies from an opti- mized, prequalified component library or design space, and receive them within six weeks. We main- tain safety stock of every single-use component in this library, and pro- vide all the required quality and regulatory documentation, thus enabling fast implementation and reliable delivery. Mobius assemblies help minimize schedule disruptions and delays. For example, pilot plants benefit from faster assembly design and delivery, allowing for the plants to adjust to new and evolving needs in real- time. In addition, contract manu- facturing organizations benefit from more reliable lead times, which allows for better planning and helps ensure on-time product delivery. SINGLE-USE IN BUFFER PREPARATION BioPharm: What advantage(s) does single-use offer in overall buffer preparation? B u l p i n: T h e B i o C o n t i n u u m Buffer Deliver y Platform offers high accuracy for the dilution of highly concentrated buffer, and MilliporeSigma is the only sup- plier providing such an integrated offering. Our platform supplies process buffers at a fraction of the resources and facility space, result- ing in a more streamlined buffer suite and a more efficient manu- facturing process. "Mobius Select gives users the ability to design configured single-use assemblies from an optimized, prequalified component library or design space, and receive them within six weeks." —Andrew Bulpin, MilliporeSigma O u r plat for m is a lso a good example of the high deg ree of connectivity that contiGuous bio- manufacturing can achieve. T h e B i o C o n t i n u u m B u f f e r Deliver y Platform offers highly accurate and precise buffer dilu- tion by using buffer concentrates a nd i n - l i ne d i lut ion d e l ive r y d i rec t ly i nto t he system. T h is streamlines the buffer deliver y step and reduces the process foot- print by eliminating massive buffer holding tanks that would normally be used buffer preparation. We estimate that the platform can provide: • 18% reduction in cleanroom area from the use of buffer concen- trates in a 20 0 0 -L bioreactor facility • For the same facility, buffer con- centrates reduce costs up to 16% over made-in-house buffers • For a facility of 5 X 2000-L bio- reactors, buffer concentrates reduce labor and capital expen- diture associated with buffer preparation by ≥50%.

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