monoclonal antibody - Bioprocess Development Forum

Articles Downstream Upstream

November 15, 2024

Production of a highly concentrated monoclonal antibody

CytivaDemonstrating an end to end mAb process with final concentration over 200 g/L Subcutaneous (SC)…

Jeanne Linke

Articles Downstream

August 13, 2024

A high-throughput study of sodium hydroxide cleaning efficiency for protein A resin

Cleaning-in-place (CIP) of chromatography resins is important for the integrity and safety of the final…

Ross Burns

Articles Regulatory

August 8, 2024

Address the complexity of protein characterization

Since the FDA approved the first monoclonal based therapy in 1985, mAbs have had significant…

Ross Burns

Articles

September 21, 2023

High-concentration monoclonal antibody drugs: manufacturing challenges

The growth in the formulation of drugs suitable for delivery by subcutaneous (Sub-C) injection...

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Articles Regulatory

May 20, 2021

Evaluation of Fibro PrismA for Scalable Single-Use mAb Purification

In clinical monoclonal antibody (mAb) manufacturing, capture on protein A chromatography resin gives...

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Articles

May 24, 2018

Chromatography Scale-Up: Don’t Get Tied Down by Bed Height

When scaling, you can make better use of existing chromatography columns while avoiding overcapacity.

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Articles Multimedia

May 24, 2018

Cleaning Protein A Resins with 1 M NaOH

With increasing mAb titers, the impurity level of the cell culture feed increases. If not…

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Articles

May 9, 2018

Capacity and Performance of a Next Generation Protein A Chromatography Resin

MabSelect™ PrismA is a protein A resin of which both the ligand and the base…

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Articles BioPharma

February 23, 2017

Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution

The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions...

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Articles

March 30, 2016

A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications

The Chinese hamster ovary (CHO) cell lines used for the production of recombinant therapeutic proteins...

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