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September 01, 2019
Particulates or aggregates are a notable challenge for injectables, but there are several methods available to help with identification during formulation and development.
Stability testing for biologics is more complex than for small-molecule drugs, so companies should be aware of the potentially serious issues that can be costly and jeopardize drug development.
As regulatory guidance has evolved, changes in CCIT testing have also become apparent. In this article, possible CCIT strategy approaches are outlined.
October 15, 2018
Providing analytical data on the comparison between a biosimilar and the reference product is a primary consideration in the development of biosimilars.
Experts discuss best practices for performing glycan analysis.
The testing of raw materials is essential as raw material quality determines the outcome of biologic product quality.
This article discusses why it is important to apply risk analysis, QbD, and DoE in the development of analytical methods.
August 01, 2018
Materials in contact with a drug must be fully characterized to ensure they do not negatively affect the safety and efficacy of the product.
March 01, 2018
Statistical methods to identify critical process parameters and critical material attributes-and approaches to control them-are needed to protect drug product and drug substances.
October 24, 2017
This article examines how process characterization is crucial to process understanding and then applying that understanding to controlling a process.