Search results for " Phase III"
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Vaccine Development and Production Challenges Manufacturers
Scientists recently reported positive clinical trial results, particularly from a large Phase III study in Latin America of a tetravalent Dengue vaccine developed by Sanofi Pasteur.
And a malaria v…
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What is process development?
By the time you reach Phase III in the drug development process, ‘good enough’ is not sufficient. Instead, you will switch your focus to making sure you have a robust upstream or downstream process th…
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Ajinomoto Bio-Pharma Services, CytoDyn in Manufacturing Partnership for COVID-19 Drug
On May 5, 2020, Ajinomoto Bio-Pharma Services (Aji Bio-Pharma), a contract development and manufacturing organization, announced that it has entered into a manufacturing services agreement with Cyto…
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Taking a “Development-by-Design” Approach to Cell Therapies
…ific treatments, were in clinical trials or being reviewed in the United States alone, 15 of them in Phase III trials (1).
The road is littered with failures, however, often in clinical stages. T…
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Use of Multivariate Data Analysis in Bioprocessing
Apr 06, 2015
By Anurag S. Rathore, Sumit K. Singh
BioPharm International
The ever increasing demand of biotherapeutics, together with the pressure to contain healthcare costs have motiva…
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Lessons Learned Accelerate Vaccine Development
Vaccine manufacturers at that point committed to accelerate their development and manufacturing activities and, in doing so, move from Phase I to Phase III in months and, should the need arise, suppor…
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GMP Challenges for Advanced Therapy Medicinal Products
This proposed that standards should become more stringent as new drugs move from the discovery stage through to Phase III clinical trials and market launch. It is also in line with the emphasis placed…
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Host-Cell Protein Measurement and Control
Jun 01, 2015
By Fengqiang Wang, PhD, Daisy Richardson, Mohammed Shameem
BioPharm International
Volume 28, Issue 6, pg 32–38
Host-cell proteins (HCPs) constitute a major part of proce…
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Biopharma Manufacturers Respond to Ebola Crisis
Boston-based MediVector has been working with Fujifilm to conduct Phase III trials in the US for influenza protection, and DOD is supporting additional testing of favipiravir against Ebola.
Most d…
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Production of Recombinant Adeno-associated Virus Vectors Using Microcarrier Culture of HEK293T Cells
As the gene therapy projects enter clinical Phase III or get market approval, large-scale production of viruses has become a limiting factor in the industrialization of gene therapy.
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