Search results for " bioprocessing"
Article
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 on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) u…
Article
A Platform Approach to Purification of Antibody Fragments
Antibody fragments constitute a promising class of biopharmaceutical products. As compared with full length antibodies, their fragments have unique properties that make them favorable for certain th…
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Modeling Bioreactor Performance
Model effectiveness is determined by the quality and composition of the data inputs.
By Cynthia A. Challener
Bioreactor design, including the geometry of the tank and impeller and the locati…
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Advances in cell culture media technology have helped achieve safer biologics.
By Tom Fletcher, Holden Harris
Regulatory expectations for cell-culture-based biologics production processes ch…
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Design and Qualification of Single-Use Systems
The author provides a review of the concepts of design and qualification that apply to single-use systems.
By Jerold M. Martin
Single-use technologies (SUT) have made significant inroads in …
Article
Make buffer preparation more time and cost efficient with inline conditioning
Simplify Buffer Preparation
The volume and number of buffers for a typical downstream process can be considerable.
Preparation of these buffers is a challenge that in-line conditioning can o…
Article
ReadyToProcess™ Prepacked Columns
ReadyToProcess columns are high-performance bioprocessing columns prepacked with a range of bioprocess resin and are supplied ready for use. As a supplier of both the chromatography resin and the pr…
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Biopharma in 2015: A Year for Approvals and Innovations
Insiders agree that 2015 was a banner year for biopharma. Last year’s new drug approvals reached 51, besting every year since 1950. Twenty approvals (39%) went to biological drugs—up from 35% in 201…
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Selecting the Right Viral Clearance Technology
By Cynthia Challener, PhD
The introduction of adventitious viral agents is a recognized, inherent risk of biologic drug production that is well addressed by international regulatory requirements…
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CMOs Continue to Improve Overall Biomanufacturing Performance
By Eric Langer
Biomanufacturing efficiency is on everyone’s minds, being the single most important area of focus for global bioprocessing. And contract manufacturing organizations (CMOs) are on th…