Search results for " sterile" in Articles / App Notes
Article
Evaluating E&L Studies for Single-Use Systems
Small-scale assembly extraction study
The small-scale assembly option was applied to a fill/finish manufacturing process that involved the use of a single-use polyethylene mixing bag, steril…
Article
Drug Quality Key to Innovation and Access
These challenges apply to biosimilars and cutting-edge therapies, as well as to the need for modern aseptic processing methods able to reliably produce both new and generic sterile injectables. The in…
Article
Advancing Single-Use Technology Through Collaboration
By working together to harmonize the highly variable steps within the biopharmaceutical manufacturing process, both end users and suppliers are making strides toward the efficiency and integrity of …
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Asking the right questions is crucial to establishing a facility design.
By Peter Genest, John Joseph
The benefits of adopting single-use technologies in the production of biopharmaceuticals…
Article
Selecting the Right Viral Clearance Technology
By Cynthia Challener, PhD
The introduction of adventitious viral agents is a recognized, inherent risk of biologic drug production that is well addressed by international regulatory requirements…
Article
Using Single-Use Technologies in Downstream Processing
According to Nilesh Mehta, senior process engineer, Merck GTO, Sterile and Validation COE, “as new technologies become available or existing technologies are converted into a single-use format, the nu…
Article
Quality Systems Key to Lifecycle Drug Management
Jun 01, 2015
By Jill Wechsler
BioPharm International
Volume 28, Issue 6
The submission and review of manufacturing supplements is costly and time consuming for biopharmaceutical comp…
Article
Modular Manufacturing Platforms for Biologics
May 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 5
It should come as no surprise that the good design principles governing the execution of pharmaceutical manu…
Article
Continuous Chromatography: Trends, Definitions and Approaches
I have also heard comments that continuous operation requires sterile columns, which lends itself to the notion that the columns need to be disposable. Obviously, prevention of bioreactor contaminatio…
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
Such situations often result in critical drug shortages, particularly for low-cost sterile injectable products made by a limited number of generic-drug companies. FDA has been able to prevent and miti…