Search results for "sanitization"
Article
Process Chromatography: Continuous Optimization
Current protein A resins are also exposed to feeds with high concentrations of cell-culture nutrients yet are more sensitive to the high concentrations of sodium hydroxide needed for cleaning and sani…
Article
Ensuring the Biological Integrity of Raw Materials
By Catherine Shaffer
Contamination with microbes, mycoplasma, viruses, and other adventitious agents can be a significant problem in biopharmaceutical manufacturing. Although contamination can o…
Article
Evaluating E&L Studies for Single-Use Systems
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
By Irene Cecchini, Daniele Mastroianni, Silvia Rocchi, Gabriella Angiuoni
Biop…
Article
Process Chromatography Selection for Downstream Processing Applications
In order to address bioburden, one needs good sanitization methods and knowledge about likely species present in the local environment. Techniques such as closed column packing and/or the use of pre-s…
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Removing the need for cleaning and sanitization, for example, means that switching between one product and another becomes quicker and easier. One way to take advantage of this flexibility is by makin…
Article
Selecting the Right Viral Clearance Technology
“These disposable membranes remove the need for evaluation of sanitization steps and the need to evaluate aged resins. In addition, the risk of a potential viral contaminant being carried over from ru…
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
This article discusses cleaning validation of equipment dedicated to the production of a single API.
By Cristina Baccarelli, Paola Bernard, Teresa Cortellino, Oscar Cruciani, Rita Pacello, Chi…
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
Optimizing Resin Performance with Disposable Chromatography Solutions
Although the initial uptake of single-use chromatography solutions has been relatively slow, an increased need for higher-capacity resins and the demand for smaller batches has made disposable chrom…
Article
Regulatory Challenges in the QbD Paradigm
It is important to note that different considerations apply to single and multiproduct facilities, product changeover, new product introductions, open versus closed operations, and sanitization versus…