Search results for " method validation"
Article
Challenges in Analytical Method Development and Validation
For most other products, method validation is typically executed against the to-be-commercial specifications prior to process validation, which is typically initiated during the pivotal clinical phase…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
The ATP criteria, as with ICH method validation criteria, are established based on considerations for patient safety and product quality and are consistent with the capability of analytical methodolog…
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Design of Experiments for Analytical Method Development and Validation
DOE for analytical methods has three major applications: method development for new methods or those that need improvement, method validation, and quantitation of the influence of analytical methods o…
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Establishing Acceptance Criteria for Analytical Methods
%CV and %Recovery should always be included in development reports and method validation documents as report only and should not form the basis of acceptance criteria.
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Article
Tackling Analytical Method Development for ADCs
Feb 01, 2015
By Cynthia Challener, PhD
BioPharm International
Volume 28, Issue 2
The targeted therapy possible with antibody-drug conjugates (ADCs) makes them an attractive class of …
Article
Emerging Therapies Test Existing Bioanalytical Methods
The May 2018 FDA Bioanalytical Method Validation (BMV) Guidance for Industry (2) provides general guidelines for all bioanalytical assays but lacks any specifics on assays that use flow cytometry, PCR…
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HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
The Chromeleon software also has an extension pack that includes validation report templates and sequences, enabling increased automation of method validation. More companies are implementing electron…
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
…idation of Analytical Procedures: Text and Methodology, and FDA Guidance for Industry, Bioanalytical Method Validation (18, 19, 20). The parameters of the validation included specificity, linearity, …
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Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I
This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…
Article
PDA's Technical Report for Biotech Cleaning Validation
Although degraded fragments of the active ingredient are measured in a cleaning-validation protocol, analytical method validation is typically performed with the bulk active itself because this typica…