Novo Nordisk licenses a once-weekly oral GLP-1/GIP candidate, uniQure reports 48-month Huntington’s disease data, and AstraZeneca invests $2 billion in Summit Therapeutics.
|Articles|May 15, 2002
- BioPharm International-05-01-2002
- Volume 15
- Issue 5
Freezing Bulk-Scale Biopharmaceuticals Using Common Techniques ? and the Magnitude of Freeze-Concentration
by Serena Donnelly Webb, David F. Sesin, Aimee C. Kincaid, Jonathan N. Webb, and Timothy G. Hughes, Integrated Biosystems, Inc. Large-scale freezing and thawing is commonly used in biopharmaceutical manufacturing but is not well understood. Freeze-thaw variations can exist within or between batches, and nonuniform processes raise serious validation concerns.
Advertisement
Articles in this issue
over 24 years ago
Info+over 24 years ago
Analytical Advances: Strategies in Clarifying Mammalian Culturesover 24 years ago
Analytical Advances: Using Image Informatics - Focusing Proteomicsover 24 years ago
The Not-So-Sure Thingover 24 years ago
Washington Report: Vaccine Shortages put Spotlight on Productionover 24 years ago
Guest Editorial: Validation Bingoover 24 years ago
Travel Notes: Yes, Virginia, There is Biotech in the CommonwealthAdvertisement
Related to this article
Novo gains global rights, excluding Greater China, to HRS-1596, a phase 1-ready GLP-1/GIP dual receptor agonist that Hengrui says has potential for once-weekly oral dosing in obesity and type 2 diabetes.
NouvSight001 isn't limited to the RPE65-mutation subset current gene therapy treats, potentially reaching more of the 1.5 million with RP worldwide.
Updated 36-month data in 15 high-dose patients showed 80% slowing on cUHDRS, while the 48-month cUHDRS result did not reach statistical significance. uniQure attributes the gap to attrition in the external control, and the FDA is reviewing a BLA based on the 36-month data.
Ivonescimab, in phase 3 trials across 8 tumor types, will be paired with sonesitatug vedotin in new gastrointestinal cancer trials.
Today’s biopharma news highlights how new data could reduce treatment burden, improve excipient information sharing, and shape future options for patients with difficult-to-treat cancers.
Daiichi Sankyo and Merck pulled ifinatamab deruxtecan's FDA filing in small cell lung cancer after a 187-patient trial fell short.
IPEC’s EIP user guide streamlines information exchange and response times while increasing accuracy through standardization.
Advertisement
Advertisement