Search results for " event" in Articles / App Notes
Article
Emerging Therapies Test Existing Bioanalytical Methods
FDA, Guidance for Industry: Gene Therapy Clinical Trials—Observing Subjects for Delayed Adverse Events (Rockville, MD, November 2006).
4. FDA, Guidance for Industry: Preclinical Assessment of Inve…
Article
Successfully Moving Regulated Data to the Cloud
This provides a significant level of protection because it would take more than one person to perform an adverse event.
Moving from an on-premise environment to the cloud
Moving to the cloud can…
Article
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
…ous and continuous detection to analyze the performance of hundreds to thousands of affinity binding events on a chip surface. In SPR imaging, the incidence angle remains fixed and the binding of bio…
Article
Web Chat June 19: Challenge Cytiva Scientists with Multistep Purification
Automated multistep (or multidimensional) protein purification is used to free up time, increase throughput, and reduce intermediate sample storage.
Join us for a free, one-hour web chat to dis…
Article
Biopharma Says It Has an Evolution in New Technologies and Processes
Rita Peters, editorial director of BioPharm International, shares observations of the magazine’s editorial team as they reported on industry developments at the April event.
Q: What insight did F…
Article
Understanding Validation and Technical Transfer, Part I
From 1970-1973, a series of septicemia events in hospitals throughout the United States due to contaminated IV fluids were linked to inadequate container-closure systems and terminal sterilization con…
Article
Modern Manufacturing Key to More Effective Vaccines
Powaleny, “New Report and Event Examine the New Era of Vaccines,” The Catalyst, Nov. 9, 2017.
2. Sanofi, “Sanofi Updates Information on Dengue Vaccine,” Press Release, Nov. 29, 2017.
3.…
Article
Impurity Testing of Biologic Drug Products
“On the other hand, the impurity may exaggerate or enhance the therapeutic protein’s bioactivity in an uncontrolled way, leading to adverse events. Some impurities (especially host cell proteins) may …
Article
Unifying Continuous Biomanufacturing Operations
Although these drugs only exploit continuous techniques upstream, experience with this type of process upstream may help to eventually inform end-to-end manufacturing solutions. As the concept of inte…
Article
Protein Purification Questions and Answers from ÄKTA Club Web Chat
Web chats, where Cytiva experts answer questions about protein purification and ÄKTA lab-scale systems during a live session, are recurring events within ÄKTA club.
Questions and answers…