Search results for " process monitoring"
Article
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…
Article
Assessing Manufacturing Process Robustness
A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.
By: Ajay Pazhayattil, Sanjay Sharma, Amol Galande, Marzen…
Article
Mapping a Route for Cell and Gene Therapy Process Development
While cell and gene therapies differ in many ways, some of the best practices for process development and validation are similar.
By Cynthia A. Challener
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Article
Single-Use Technologies Prove Effective for Viral Vector Process Development
“These single-use bioreactors deliver high cell densities in a reduced footprint while offering in-line process monitoring capabilities, facilitating operations. In addition, their reduced operational…
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…
Article
Continued Process Verification for Biopharma Manufacturing
The authors discuss complications of implementing continued process verification and provide recommended approaches.
Oct 1, 2014
By: Jeff Fleming, Robin Payne
BioPharm International
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Article
Digitalization: The Route to Biopharma 4.0
However, most of these systems lack or at best offer limited abilities for process monitoring or control. Researchers have attempted to create mechanistic models that can predict the impact of major p…
Article
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…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
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.
T…
Article
Improving PAT for Biologics
If the cell metabolism is known, the detection of changes as secondary indicators can be adopted as PAT techniques for process monitoring, even if the active compound to be produced cannot be detected…