Search results for " PAT"
Article
QbD Improves Cell-Culture Process Control
In addition, this use of PAT would allow for on-line prediction of the critical quality attributes (CQAs) required to maintain product quality and offer the ability for real-time product quality contr…
Article
Improving Upstream Predictability
Leveraging PAT and sensor technology, it will feature a modular design and use portable 2000-L bioreactors and vessels and single-use bioreactors.
At the contract development and manufacturi…
Article
Optimizing Late-Stage and Commercial Cell-Culture Processes
“Inline monitoring and real-time control of critical nutrients such as glucose and glutamine lead to more optimal and robust processes, and there is an increasing trend to adopt such PAT methodologies…
Article
Making the Move to Continuous Chromatography
Some systems come with flow paths that are designed to be cleaned and reused, while others are flow paths that are single-use. Some systems come with dynamic control functionality—process analytical t…
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
Cleaning in the GMP industry is a critical process intended to prevent or, in more modern terms, reduce risk of contaminating the subsequent product with undesirable residues that may impact patient s…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
The overall effort builds upon the agency's Critical Path Initiative, launched in 2004, to drive innovation in scientific processes, which includes the 2011 report that prioritized eight areas, which …
Article
Cell-Culture Advances Test Bioreactor Performance Models
“Successful modeling of bioreactors can reduce costs associated with engineering testing and engineering runs, accelerating pathways through preclinical and early clinical phases,” adds Mark T. Smith,…
Article
Technologies and Practices Must Evolve to Meet Demand
More than 42% cited better process understanding and increased efficiency or reduced waste as primary drivers for implementing PAT. High performance liquid chromatography was the leading technology, r…
Article
State of Quality and Compliance in the Biopharmaceutical Industry
There needs to be a shift in thinking, attitudes, and behaviors so we don't place our companies, employees, and patients at risk when getting things done "now" is valued more than doing what is best f…
Article
Regulatory Challenges in the QbD Paradigm
The past five years have seen QbD gaining widespread adoption in the biopharmaceutical industry with several publications attempting to elucidate a path forward for its implementation and resolution o…