Search results for " characterization"
Article
Virus-like Particles as Therapeutic Moieties of the Future
…status of VLPs as therapeutics as well as challenges associated with their analytical and functional characterization. Concerns related to their stability are also discussed.
Applications of VLPs…
Article
Tackling Analytical Method Development for ADCs
Their composition--a biologic linked to a small-molecule cytotoxic, which enables targeted delivery--also creates challenges for analytical method development, both for characterization and lot releas…
Article
Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
Figure 1: Characterization of a model one-dimensional process space spanning a range of pH values.
In reality, many factors influence process performance and these may interact with each …
Article
Analyzing Proteins Using SEC, MALS, and UHPLC
The characterization of proteins involves identification of their complex chemical and physical structures and requires the use of a range of analytical techniques. Size exclusion chromatography (SEC)…
Article
Reimagining Affordable Biosimilars
This characterization is typically followed by preclinical studies for evaluating pharmacology (e.g., pharmacokinetic [PK], pharmacodynamic [PD], immunogenicity) and toxicology (e.g., small and large …
Article
Design of Experiments for Analytical Method Development and Validation
Design of experiments (DOE) is a well-proven characterization approach within product and process development and a key aspect of quality by design. Recently, more attention has been placed on applyin…
Article
Impurity Testing of Biologic Drug Products
The requirement to establish an analytical method depends on whether it is for an identity test, content test, or purity/impurity test; whether it is for release, in-process testing, or characterizati…
Article
QbD and PAT in Upstream and Downstream Processing
In the case of biosimilar products, the bioanalytical characterization of the originator product provides another useful input to determine the significance of product and process variability.
Web…
Article
Biosimilar Quality Requirements
Understanding the physicochemical and biological characteristics of the reference product, doing a full characterization, and familiarizing oneself with publicly available information on the reference…
Article
Addressing the Complex Nature of Downstream Processing with QbD
…eed for a platform approach to manage the early phases of drug development and conduct more detailed characterization towards late-stage process development,” he says.
To address this challenge, …