Search results for " sterile" in Articles / App Notes
Article
Microbiological Testing: Time is of the Essence
Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing methods.
By Cynthia A. Challener
Effective microbiological testing during biopharmace…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
Some other surgical products are not manufactured to be sterile at all, also posing risk. Each of these situations is the result of risk assessments that are based on the nature of the product and its…
Article
Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I
This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…
Article
Best Practices in Qualification of Single-Use Systems
Final drug-product sterile filtration and transfer using SUS has also being increasingly applied to fill/finish operations.
Figure 1: Typical mAb manufacturing process.
The implementation of …
Article
Selecting a Comprehensive Bioburden Reduction Plan
Chromatography resins, for example, are not typically provided sterile or capable of being sterilized, so they are a potential source of contaminations unless cleaned, sanitized, and stored correctly.…
Article
Achieving Process Balance with Perfusion Bioreactors
The choice of the cell retention system, its filter pore size, and its integration or sterile connection to the bioreactor are of fundamental importance for all types of perfusion processes, agrees Th…
Article
Bioburden Control in the Biopharmaceutical Industry
Field, “Bioburden Control at the Sterile Filtration Step: A Risk-Based Approach,” presentation to European Biopharmaceutical Enterprises (May 2013).
10. Critical Process Filtration Inc., “Partic…
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
Automation Trend in Fill/Finish Reduces Contamination Risk
Handling sterile liquids in the pharmaceutical industry has traditionally relied on consistent techniques over the past 100 years, and changes in technology and regulations have been relatively slow, …
Article
The New World of Biopharmaceutical Manufacturing
Galliher, chief technology officer, Upstream, Cytiva; Sabrina Restrepo, associate director in the Sterile & Validation Center of Excellence, Global Technical Operations at Merck; Helene Pora, PhD, vic…