Search results for " Critical process parameters"
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Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I
This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…
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The Lifecycle Change of Process Validation and Analytical Testing
In the two years since the publication of FDA's final process validation guidance, how has this new lifecycle approach affected the way the industry performs validation? BioPharm Internati…
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Assessing Manufacturing Process Robustness
Stage 1, process design assessment, involves the following steps:
determining the quality target product profile and justification of critical quality attributes (CQAs) and critical…
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Mapping a Route for Cell and Gene Therapy Process Development
…e scaled process can consistently produce the final product, meeting the CQAs based on the specified critical process parameters and critical material attributes. To achieve this goal, according to B…
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Addressing the Complex Nature of Downstream Processing with QbD
Critical material attributes (CMAs) and critical process parameters (CPPs) are identified through product design and understanding. Specifications for the drug substance, excipients, and drug product …
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Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…
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Digitalization: The Route to Biopharma 4.0
Industry 4.0, also known as the Fourth Industrial Revolution (4IR), will result in the digital transformation of the manufacturing sector. It is propelled by transformative trends such as the prolif…
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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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Improving PAT for Biologics
“Often, secondary metabolites and related parameters must be detected as critical process parameters and monitored to track the batch status in real time, which requires a lot more process understandi…
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Remote Monitoring and Big Data Advance Upstream Automation
There must be functionality that benefits everyone from high-level management monitoring key performance indicators to operators monitoring critical process parameters and acting on prescriptive actio…