Search results for " reliability"
Article
Reliability Rooms and the Move to Proactive Supply Chain Management
A cross-functional team from quality, customer logistics, global planning, and affiliate services, facilitated by the global reliability team, has put in place a revised process, simplified procedures…
Article
Cytiva Announces Digital Collaboration with Amgen To Improve Biomanufacturing Performance Reliability
Cytiva announced a digital data exchange collaboration program with Amgen, which will include advanced data analytics to increase the understanding of the relationship between raw material variability…
Article
Your Reliable Downstream Bioprocessing. Our Proven AxiChrom Columns
The goal for biopharmaceutical manufacturers is to develop a process that will deliver material for clinical trials quickly and smoothly, achieve success in these trials, and scale up to commercial …
Article
CoAs Help Secure the Supply Chain
The purchaser still needs to establish the reliability of the container/closure suppliers through the audit process, but CoAs can be used to help determine the consistency of the supplier over a perio…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Several computational statistical methods are available for analysis of process reliability. Each of these requires specialized statistical software.
These methods include:
…
Article
Achieving Process Balance with Perfusion Bioreactors
Bioreactor probe reliability is crucial due to fouling and longer process durations. “Perfusion bioreactors require system integration, particularly for fine-tuning of the media feed. The control stra…
Article
Trends in Single-use Bioreactors
Issues with reliability
BioPharm: What are some of the current reliability issues with single-use bioreactors and how are they best resolved?
McNeil (Thermo Fisher Scientific): Recent challeng…
Article
Drug Quality Key to Innovation and Access
FDA plans to advance initiatives for ensuring reliable production of drugs and biologics in 2017.
By Jill Wechsler
Amidst multiple challenges to the structure and governance of the US health…
Article
Improving PAT for Biologics
The complexity of biopharma processes requires innovative solutions.
Dec 01, 2014
By Cynthia Challener, PhD
BioPharm International
A key component of the quality-by-design (QbD) ap…
Article
Moving PAT from Concept to Reality
“The lack of availability and reliability of cost-effective in-line/on-line analytical sensors needed for the measurement of CQAs and product-related species is one of the gaps in continuous processin…