Search results for "raw material variability"
Article
Technology Innovations Improve Process Chromatography Performance
As technology matures, inefficiencies and process limitations in downstream process chromatography are improved.
By Feliza Mirasol
Selecting an appropriate separation technology fo…
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Single-Use Technologies Prove Effective for Viral Vector Process Development
The benefits of single-use technologies for upstream viral-vector processes clearly outweigh their disadvantages.
Cynthia A. Challener
Upstream viral-vector processes can have sig…
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Understanding Validation and Technical Transfer, Part 3
For example, the impact of raw material variability or commercial-scale processing conditions on quality attributes may not have been fully determined. These factors are usually related to production …
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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…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Stage 2 (process qualification) has a limited number of commercial-scale runs to provide confidence in the control strategy developed in Stage 1 and cannot fully explore all raw material variability. …
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
A…
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Using Digital Twins to Model Process Chromatography
Accordingly, fully developed digital twins will foreseeably play an important role in handling raw material variability, batch control, and real-time release testing in the future.
One of the larg…
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Reimagining Affordable Biosimilars
Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.
By Anurag S. Rathore, Narendra Chirmule, and Himanshu Malani
Drug development is …
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Design of Experiments for Analytical Method Development and Validation
Design of experiment is a powerful development tool for method characterization and method validation.
Design of experiments (DOE) is a well-proven characterization approach within product…
Article
Moving PAT from Concept to Reality
“Regulators expect process monitoring and controls based on the entire batch data and the ability to revise controls to compensate for raw material variability or the use of different batches of raw m…