Search results for "development"
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Host-Cell Protein Measurement and Control
Therefore, it is a regulatory requirement to monitor the removal of HCPs in drug product during bioprocess development.
HCPs are proteins produced or encoded by the host organisms used to produce …
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Emerging Therapies Test Existing Bioanalytical Methods
Current FDA guidance provides little direction on how to approach assay development and validation when using these emerging technologies, nor is there guidance for the application of more familiar te…
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
In the past few years, there has been an increase in the number of therapeutic proteins in development and those that have received approval from regulatory agencies. Proteins are produced by gene exp…
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Robust Optimization, Simulation, and Effective Design Space
Developing product knowledge and process understanding is at the heart of modern drug development. Establishing a clear line of sight between critical quality attributes (CQAs), process parameters, an…
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Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
Development of Novartis’ technology and construction of the plant were funded in part by the HHS Office of the Assistant Secretary for Preparedness and Response and the Biomedical Advanced Research an…
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Regulatory Challenges in the QbD Paradigm
This decline in success rate, along with the increasing scrutiny of healthcare costs in developed economies, has resulted in unrelenting pressure on the pharmaceutical companies to control drug-develo…
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Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
Adherent cell lines are the most common choice at early stages of development as they are readily sourced, easy to cultivate at the laboratory scale, and require less expert bioengineering know-how.
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Eliminating Residual Impurities Starts with a Strategic Plan
It also allows the development of an optimal process with a suitable control strategy and test methods in a timely fashion.
The implementation of a risk-based strategy for the testing of residua…
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Advances in Engineering of Protein-Based APIs
… enabling chronic treatment without liabilities, according to Jennitte Stevens, director of process development at Amgen. Generation of fully human antibodies is achieved in transgenic animals. For i…
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Understanding Validation and Technical Transfer, Part 3
Initially, development information can be kept in research or laboratory notebooks, but as clinical use becomes likely, formal development reports and initial validation work should be prepared, revie…