Search results for " chromatography scale-down"
Article
QbD and PAT in Upstream and Downstream Processing
To gain perspective on the implementation of quality by design (QbD) and process analytical technology (PAT) in biopharmaceutical processing, BioPharm International spoke with Clinton Weber, as…
Article
Moving PAT from Concept to Reality
The learning curve for process analytical technology has slowed widespread adoption.
By Cynthia A. Challener
alexlmx a- Stock.Adobe.com
Process analytical technology (P…
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Report from the 6th International HTPD Conference
The biggest challenge is still the people and Quantitative Structure-Activity Relationship (QSAR) plus mechanistic modeling were two key take-home messages from the 6th International conference devote…
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New HiScale™ 10/40 for Scale-Down Studies
Cytiva is pleased to announced the new HiScale™ 10/40.
HiScale 10/40 column is especially suitable for scale-down studies used in, for example, viral clearance evaluation in downstream processing. …
Article
New Column for Scale-Down Studies
Cytiva is pleased to announce new Validation columns.
Their dimensions—narrow 10 mm inner diameter, combined with 20 cm bed height typically used in biomanufacturing—make these columns suitable …
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Putting Viral Clearance Capabilities to the Test
Process understanding and careful assessment of risks are essential in developing viral clearance programs.
By Rita C. Peters
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Being Thorough When Transferring Technology
Communication and taking the time to develop the process are key to successful transfer and scale up of biologics.
By Susan Haigney
Editor's note: The following is an extended version of the…
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FAQ: Scale-up and scale-down with mechanistic modeling
A mechanistic model can simplify your process development projects. The model eases scale-up and scale-down between lab scale and production scale. To apply model-based scale-up and scale-down…
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Viral Clearance Challenges in Bioprocessing
Challenges remain for virus removal and validation.
Nov 1, 2014
By: Cynthia Challener, PhD
BioPharm International
Volume 11, Issue 27, pp. 42-44
Removal and inactivation of adventitio…
Article
Downstream Processing for Cell-Based Therapies
By Qasim A. Rafiq, Fernanda Masri
With increasing numbers of advanced therapies—including cell and gene therapies—entering early- and late-stage clinical development, significant focus has been …