Bayer Healthcare LLC

Paul Wu

Konstantin Konstantinov

Deqian Wang

Jens Holger Vogel

Arnaud Desponds

Huong My Nguyen

Omkar Joshi

Roberto Giovannini

Nelly Tsvetkova

The present invention relates to a process and apparatus for purifying a molecule of interest from a heterogeneous clarified fluid mixture. The apparatus of the invention generally comprises a continuous perfusion fermentation system, a continuous particle removal system integrated with the perfusion fermentation system; and a continuous purification system integrated with the particle removal system, which is maintained under sterile conditions. The process comprises filtering a heterogeneous clarified fluid mixture by continuous ultrafiltration at a specific flow rate below the transition point of the molecule of interest in the pressure-dependent region of the flux versus TMP curve, wherein the specific flow rate is maintained substantially constant throughout the continuous ultrafiltration.

Devices and methods for integrated continuous manufacturing of biological molecules

The invention relates to a method for stabilizing a bulk solution of recombinant protein for frozen storage, which comprises providing a partially-purified solution of recombinant protein which has a monovalent salt concentration of at least 100 mM, and adding a carbohydrate to said solution in an amount sufficient that, upon freezing, the solution has a glass transition temperature of &#x2212;56&#xb0; C. or higher.

Stabilization of liquid solutions of recombinant protein for frozen storage

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Orinda, CA, United States of America

Paul Wu