Search results for " bioprocesses"
Article
Biopharma Seeks Balance
…cing, continuous manufacturing for downstream processes, and a manufacturing platform for continuous bioprocesses (2).
New challenges to manufacturing
Manufacturing processes have tr…
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Miniaturization to Become Even More Successful
Industrial bioprocess development has changed significantly in the last decade, driven primarily by two major factors: ever-rising R&D costs of developing therapeutic candidates with simultaneous de…
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Putting Viral Clearance Capabilities to the Test
Challenges in study design
The multi-step nature of bioprocesses—and the viruses themselves—present challenges to the development of viral clearance studies and limit their effectiveness.
“All…
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Cleaning Protein A Resins with 1 M NaOH
With increasing mAb titers, the impurity level of the cell culture feed increases. If not removed, these impurities can build up on the protein A resin and start to leach into the process material i…
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Going Viral
How a new factory-in-a-box is helping scale up manufacturing of viral vector-based therapies to reach more patients.
Manufacturing viral vector-based therapies such as vaccines and gene…
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Flow Accuracy and Gradient Performance of ÄKTA pilot 600 Chromatography System
Accurate flow is important for your chromatography step to provide reproducible results at different scales. A comparable flow accuracy between scales can facilitate scaling of your methods.
In…
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Biopharmaceutical Market in Asia: Q&A with Günter Jagschies, Strategic Customer Relations Leader, Cytiva
This week, the Process Development Forum talks with Günter Jagschies, Strategic Customer Relations Leader, Cytiva, about the biopharmaceutical market in Asia.
The Asian market is most often s…
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Applying GMPs in Stages of Development
Applying GMPs in Stages of Development
Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety, …
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Evaluation of Performance of a Disposable mAb Affinity Chromatography Column Used Over Multiple Process Cycles
Presanitized and prequalified disposable chromatography columns are widely used to save time in downstream processes. However, reuse of such columns could positively impact process economy. This app…
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Efficient Cleaning-In-Place Methods for Protein-Based Antibody Affinity Chromatography Resins
This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments, for example, Fab fragments. Various cleaning strategies and …