Search results for " event" in Articles / App Notes
Article
Reconciling Sensor Communication Gaps
“By the time you’re done you’re measuring something that existed up to three hours ago--you’re looking into the past and potentially missing an event that caused stress on the cell,” McNeel says. Henc…
Article
Ensuring Sterility in Small-Scale Production
It should also define how operators will be periodically requalified and how operators will be requalified in the event of an out-of-specification result. Operator aseptic technique should be tested t…
Article
Biosimilars to Drive Modern Manufacturing Approaches
Concerns about adverse events have diminished as biosimilar use has expanded in Europe. As more competitors enter biosimilar markets, Gal expects discounts will rise from the 30% range to more than 75…
Article
Establishing Acceptance Criteria for Analytical Methods
Effectively the question is: how much of the specification tolerance is consumed by the analytical method? Finally, how does the method contribute to OOS events when releasing product to the clinic or…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
In concert, these measures would greatly enhance a quality-based viral risk mitigation program and a firm’s readiness to respond to a contamination event.
Product development
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Article
Biopharma in 2015: A Year for Approvals and Innovations
Continuous processing escalated in 2015 and was discussed at almost every bioprocess conference or event. This trend was apparent on PDF, where articles on continuous downstream processing generated a…
Article
Selecting a Comprehensive Bioburden Reduction Plan
Bioburden problems often result from a lack of understanding of personnel actions that result in a process or product contamination event.
Filtration
BioPharm: How do endemic bacteria affect t…
Article
Robust Optimization, Simulation, and Effective Design Space
The effective design space is the region where no OOS events occur and/or the applicant will adjust to correct for processing conditions, raw material potency, and/or dose or formulation requirements.…
Article
Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 4
Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …
Article
What Drove Biopharma Development in 2014?
The global monoclonal antibody market size exceeded $80 billion in 2013, and could reach $141 billion by 2017, according to Paradigm Global Events, an independent business information provider.
PD…