Driving Advancements in Biopharmaceutical Manufacturing

PAK BioSolutions Submits Patent Application for Solid, Single Use Flow Kit

Jan 31 2019

Alexandria, VA, – A patent application has been submitted for a solid, single use flow kit designed for purification of monoclonal antibodies and other biopharmaceuticals in a continuous manufacturing process.  The flow kit will be installed in an automated system to be designed by PAK BioSolutions and provides the basis for the pilot scale line of product offerings.  “Our flow kit will enormously simplify process setup – one of the biggest challenges of an end-to-end continuous process,” said Joanna Pezzini, President and founder of PAK BioSolutions.

Continuous purification processes provide significant productivity improvements and reductions in capital costs; however, operation of each manufacturing step simultaneously increases complexity of the flow path. The PAK flow kit is designed to simplify and streamline process setup.  A single flow kit design is used for all stages of the purification process – identical flow kits are placed in series as steps are added – reducing inventory part numbers and quantities.

The patent application, officially titled “Therapeutic Protein Flow Kit for a Continuous Purification System” describes a single, compact, integrated piece comprising a static mixer, a mixing vessel, a plethora of input and outlet lines for the products and the addition of solutions, pH and conductivity probe connections, and a sampling connection.

The integral nature of the flow kit provides for a compact device that can be seated alone or in a bank of multiple kits, utilizing far less lab space than previous non-integral versions with masses of loosely held tubing and connections.  The kits can be laid on a tabletop without further need for stabilization.  Additionally, they can be placed on a stir plate and scale to for mixing and weighing.

The flow kit is made of nylon 12 that meets USP Class VI specifications for use in pharmaceutical processes and has excellent chemical resistance.  The flow kits will be sold as a gamma irradiated assembly that includes all associated tubing and sampling connections.  The company expects the solid, single use flow kit to be the next evolution in single use equipment used by pharmaceutical manufacturers and to further push the industry away from traditional stainless-steel infrastructure.

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