Search results for " Phase III"
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle.
With the most recent FDA …
Article
mAbs to Watch in 2016
mAbs in development
Most of the products listed below are in Phase III trials; however, a few are in earlier stages of development. Although the pharmaceutical manufacturers developing these mAbs …
Article
ADC Development Robust Despite Lackluster Performance
In addition to having Adcetris on the market for cHL and ALCL, the company is also further developing the ADC for other indications, including in three Phase III clinical studies to evaluate its poten…
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Applying GMPs in Stages of Development
In Phase I/II of the development process, you may only decide to document the source and quality of the material used to produce the product; when you enter into Phase III you will want to qualify yo…
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.
By Satish Mallya, Benjamin Lay, Lihong McAleer, Alexa…
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Can Vaccine Development Be Safely Accelerated?
Can Vaccine Development Be Safely Accelerated?
Biopharma companies responding to the COVID-19 outbreak think accelerating the development of vaccines is safe.
By Cynthia A. Ch…
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Putting Viral Clearance Capabilities to the Test
The manufacturing limits of parameters in these steps that might have an impact on the virus reduction should be challenged in the virus validation studies prior to Phase III, to show the robustness o…
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Impurity Testing of Biologic Drug Products
Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
By Adeline Siew, PhD
CA-SSIS/shutterstock.comIm…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells.
By Luhong He, Christopher Frye
Abstract
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Article
Breakthrough Drugs Raise Development and Production Challenges
…with FDA after Phase II studies, approximately two years ahead of a traditional NDA that is based on Phase III data. The time reduction presents “significant challenges to the development team,” he c…