This study, performed with a prototype system, is designed to confirm the system’s suitability for concentration and diafiltration steps to high final concentrations up to 150 g/L.
This case study shares the work of GE’s Fast Trak Services team to help accelerate development of a process for cGMP production of material for toxicology studies.
A three-column workflow has been developed for the purification of a histidine-tagged recombinant protein from E. coli extract. The macroporous Ni2+-charged Nuvia IMAC Resin provides efficient capture of the target protein molecules with excellent selectivity, binding capacity, and recovery. The subsequent mixed-mode chromatography steps, performed with Nuvia™ cPrime™ Resin followed by CHT™ Ceramic Hydroxyapatite Media, eliminate leached Ni2+ ions and offer further clearance of residual impurities from host cells.
The formation of aggregates is a common occurrence during monoclonal antibody (mAb) purification and can happen for several reasons. Aggregates are undesirable due to the possibility of altered pharmacodynamics, pharmacokinetics, and/or increased immunogenicity.
Follow the paths of two companies as they learn how a science-led, risk-based development approach yields a more successful outcome in the long run.
Why manufacturers must carefully evaluate the potential impact of a prefilled syringe on product quality by conducting laboratory studies prior to selecting the final components. In particular, assessing the impact of silicone oil and tungsten residues is crucial.
This video highlights a state-of-the-art, 100,000L-capacity manufacturing facility capable of producing modern, high-flow agarose resins.
Overcome the cost, time, and risk pressures of bringing MAb products to market.
This video demonstrates proper packing technique, provides practical media handling tips, and gives specifications for optimal hardware and process conditions.
Address optimal configuration of a multi-column continuous chromatography (MCC) system, with insight into the impact antibody titer has on the number of chromatography columns required to optimize productivity of a MCC process.
Examine common regulatory challenges and areas of uncertainty in the implementation of continuous bioprocessing, and understand practical, total solutions.
ÄKTA readyflux is an automated single-use filtration system for pilot- and small-scale manufacturing. The system is intended for crossflow (also called tangential flow) filtration applications in both upstream and downstream workflows.
This automated single-use filtration system for pilot- and small-scale manufacturing features a single-use flow path that addresses the bioburden challenge, reducing the need for cleaning to shorten batch changeover time.
By Brandy Sargent, Editor In Chief, The Cell Culture Dish
This article was originally published on the Downstream Column, May 17, 2017 and is reprinted here with permission - https://downstreamcolumn.com/cool-tools/pre-activated-resins-ligand-immobilization-facilitate-creation-customized-affinity-purification-media/
In the development of biopharmaceuticals there are times when an off the shelf affinity chromatography medium is unavailable or isn't highly selective for the target molecule being purified. It is possible then to design a custom chromatography solution by coupling a specific ligand to a pre-activated resin.