Search results for " process characterization"
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
The purpose of this assessment is to provide a focus for the downstream process characterization work required to complete process validation Stage 1 (process design).
This initial risk assessm…
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
Quality by design for biotechnology products—part 1
This knowledge is gained during development and grows with more manufacturing experience through process characterization, scale-up, technology transfer, and manufacture, as well as through increased …
Article
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…
Article
Addressing the Complex Nature of Downstream Processing with QbD
The impact of variability regarding raw materials can be felt first in commercial manufacturing because of a lack of relevant test material during process characterization. “The only viable approach t…
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…
Article
Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
Use of a subspace model is a viable method to characterize process space variables and optimize process performance.
By Colin Jaques, Daniela Lega
Over the past decade, two improved capabili…
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…
Article
Platform Approach Speeds Process Development
In addition, small-scale systems are a prerequisite for successful process characterization studies to provide reliable evidence that process parameters and associated critical product attributes are …
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
These reasons force sponsors to initiate extensive process characterization studies and to lock the production processes early in the clinical development program (41).
One new approach to genera…