The current processing paradigm of large manufacturing facilities dedicated to single product production is no longer an effective approach for best manufacturing practices. Increasing competition for new indications and the launch of biosimilars for the monoclonal antibody market have put pressure on manufacturers to produce at lower cost. Single-use technologies and continuous upstream processes have proven to be cost-efficient options to increase biomass production but as of today the adoption has been only minimal for the purification operations, partly due to concerns related to cost and scale-up. This review summarizes how a single-use holistic process and facility strategy can overcome scale limitations and enable cost-efficient manufacturing to support the growing demand for affordable biologics. Technologies enabling high productivity, right-sized, small footprint, continuous, and automated upstream and downstream operations are evaluated in order to propose a concept for the flexible facility of the future.

High capacity salt tolerant weak cation exchange media for mAb purification: Improved process performance through efficient pH transition and control

Author: Stout, James ; Paghdal, Nirali ; Kanani, Dharmeshkumar M. ; Sidhu, Navneet

Cation-exchange chromatog. is widely used during biotherapeutics production to sep. impurities, including product related variants such as aggregates.For weak cation-exchange media, ionization of functional group depends on solution conditions, i.e. pH and conductivityThe varying degree of carboxylic acid group ionization at different pHs allows one to tune ionic interactions for improved separationHowever, the same unique feature also presents slow pH transition and difficult pH control during conductivity gradient.This study will show data on blank runs (i.e. no sample injection) conducted using solutions having different types of buffer species and salts at varying concentrations to better understand the pH transition and control during weak cation exchange chromatog.The performance difference between anionic and cationic buffers will be highlighted and how this knowledge can be used to improve mAb purification performance will be discussed.

BioProcess International

Membrance adsorbers, columns single-use alternatives to resin chromatography

Author: Jacquemart, Renaud ; Stout, James G.

Filtration membranes are used extensively throughout the biopharmaceutical industry for a range of applications fron coarse filtration to nanofiltration.Advantages of filter technologies include easy scaling,disposability,and rapid and robust performance in a single-pass.The same advantages have been realized with membrane absobers.Chromatog. resins are inherently disadvantaged by diffusion limits of the pores in chromatog. media.Therefore , resin columns must be significantly oversized to match the performance of high productivity bioreactors.By comparsion ,membrane adsorbers take advantage of filter performance to deliver highly productive downstream operations.Surface-functionalized membranes from sartorius stedim biotech and pall life sciences typically use anion-exchange groups fro MAb polishing operations in neg. mode .Such flow-through chromatogrphy operations for impurity reduction can enhance purification productivity by over an order of magnitude.Natrix seperations 3-D hydrogel membrane columns demonstrate performance upto 20,000g/l membrane for MAbs,with impressive host cell protein(HCP) and virus reduction with only six seconds of residence time.Membrane adsorbers are increasingly used in new flexible manufacturing facilities,in which speed of operations and robust performance are essential produduction criteria.These functional membranes are the first truly disposable ,single-use chromatog. media with best-in-class .

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