Search results for "Science"
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
Perkins, PhD currently at the Department of Manufacturing Science and Technology, Hospira, USA for her feedback.
REFERENCES
1. T.K. Das, AAPS PharmSciTech. 13 (2), pp. 732-746 (201…
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Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
2016 Global Life Sciences Outlook, Moving Forward With Cautious Optimism, Deloitte, https://www2.deloitte.com/content/dam/Deloitte/global/Documents/Life-Sciences-Health-Care/gx-lshc-2016-life-sciences…
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Biosimilars to Drive Modern Manufacturing Approaches
FDA’s regulation of biosimilars is “under the microscope” in Washington, she noted, but “great science” and “fit-for-purpose, innovative regulation” will support patient access to these more affordabl…
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Protein Characterization Using SEC: Three Webinar Takeaways
With more than thirty years in protein science, Åke Danielsson, Research Director at Cytiva, recently held a webinar on protein characterization using size exclusion chromatography (SEC). Here, …
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Improving Process-Scale Chromatography
…phy, according to Peter Levison, senior marketing director for downstream processing with Pall Life Sciences. These resins contain simple multimodal ligands with functional groups that interact with …
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Establishing Acceptance Criteria for Analytical Methods
Traditional Measures of Analytical Goodness and History
Historically, analytical chemists have worked on the science of an analytical method and maintained their evaluations of method goodness ind…
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
The efforts behind these achievements were driven not only by the opportunity to understand cell-culture science better, but by a variety of process-related concerns.
Many past efforts simply soug…
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Perfusion in the 21st Century
Konstantinov and CL Cooney, White Paper on Continuous Biopprocessing, Continuous Manufacturing Symposium, Journal of Pharmaceutical Sciences 104:813-820, May 20-21, 2014.
5. C. Challener, “Focus o…
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Managing Biomanufacturing Capacity Expectations
…torney at Vischer AG, who specializes in drafting and negotiating contracts for clients in the life sciences. These developments can arise because an opportunity presents itself to improve a drug or …
Article
Biosimilars: Making the Switch Comes with Challenges
But since then, there had been rapid advances in analytical sciences. The efficiency of mass spectrometry had increased to such an extent that its sensitivity had soared 10,000 fold in 10 years and 10…