Search results for " contamination" in Articles / App Notes
Article
Design and Qualification of Single-Use Systems
bioburden, endotoxins, and particle contamination or generation.
• Packaging and shipment containers must be designed to effectively protect the SUT component or assembly during transport from the…
Article
Best Practices in Qualification of Single-Use Systems
…:
• Flexibility
• Less up-front capital investment
• No batch-to-batch cross contamination
• No re-use cleaning validation
• Less work on scale up
• Shortened time-to-pa…
Article
Using Single-Use Technologies in Downstream Processing
Mehta states that the use of SUS in downstream processing may “reduce risk of cross contamination and carryover due to inadequate cleaning steps.”
BioPharm International spoke with Nilesh Mehta ab…
Article
Biopharma Advances Demand Specialized Expertise
These challenges manifest in quality issues with the final container closure and may be related to microbial contamination, glass particulates, and foreign materials that lead to necessary market acti…
Article
Continuous Manufacturing: A Changing Processing Paradigm
Biotechnology products, when run continuously, can be sampled regularly, and any process contamination can be resolved more easily without having to discard entire batches.
To take regular samples…
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
Mar 01, 2015
By Randi Hernandez
BioPharm International
Volume 3, Issue 28
Aggregation in biopharmaceuticals remains a major concern and threatens the stability of a product. Protein …
Article
Quality by Design and Extractable and Leachable Testing
The author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product.
Feb 01, 2015
By Anthony Grilli
BioPharm…
Article
Technologies and Practices Must Evolve to Meet Demand
Regulatory issues and microbial contamination, however, were of greater concern for the 2015 survey participants. Producing high enough product yields, purifying high product yields, and protein aggre…
Article
Trends in Single-use Bioreactors
…h tradition stainless-steel systems are reduced, and as a result, there is less of a risk of product contamination.
Ang (Eppendorf): One of the biggest advantages of implementing single-use vesse…
Article
Optimizing Resin Performance with Disposable Chromatography Solutions
…ilities, use of facility time, the potential cost of a repack, and the additional costs of potential contamination against the cost of buying a prepacked chromatography column. The main advantage is …