Search results for " bioanalytical"
Article
The Importance of Partnering for Bioanalytical Studies
…ing partners who have expertise and in-depth experience in developing and conducting the appropriate bioanalytical assays for a project as well as experience interacting with regulatory authorities.
…
Article
Emerging Therapies Test Existing Bioanalytical Methods
Challenges remain for development of these therapies, particularly in the bioanalytical method approach required. Questions include the following:
· How much of a dosed gene therapy is present in …
Article
Tackling Analytical Method Development for ADCs
Finally, bioanalytical immunoassays, such as enzyme-linked immunosorbent assays (ELISA) are used for quantitation of the ADC, naked antibody, and free drug content, determination of the extent of ADC …
Article
Ligand-Binding Assays and the Determination of Biosimilarity
In October 2014, the American Association of Pharmaceutical Scientists (AAPS) Ligand-Binding Assay Bioanalytical Focus Group Biosimilars Action Program Committee published a whitepaper with recommenda…
Article
An Analytical Approach to Biosimilar Drug Development
The single assay approach became the standard in the industry after 2014 when the uniform approach for determining bioanalytical biosimilarity recommended by Marini et al. (3) became widely adopted.
…
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
… Guideline Validation of Analytical Procedures: Text and Methodology, and FDA Guidance for Industry, Bioanalytical Method Validation (18, 19, 20). The parameters of the validation included specificit…
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
Join DiPIA 2022
Don’t miss out on latest applications and developments in biophysical characterization, join our two half-days conference where researchers will present their work using surface plasmon r…
Article
Process Development Webinar Library
Time to experiment, time to clinic, and time to market are becoming even more important for developers and manufacturers of biopharmaceuticals.
Cytiva’s library of on-demand webinars are de…
Article
Challenge Analytical Complexity: Biacore™ SPR Systems for Candidate Selection, Characterization, and Quality Control
This webinar presents the utility of Biacore™ systems at all stages of the process, from selection of first candidates to clinical lead, as well as how to shorten and streamline the time to results …