Search results for " assays"
Article
Design of Experiments for Analytical Method Development and Validation
Design of experiment is a powerful development tool for method characterization and method validation.
Design of experiments (DOE) is a well-proven characterization approach within product…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
Critical quality attribute identification/assay development: Identify and develop assays for critical quality attributes, potency assays—overestimate testing needs!
Methods/equipment qualific…
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Microbiological Testing: Time is of the Essence
“Occasionally the therapeutic molecule can have toxic effects on the detector cells that are used to detect viruses in in-vitro assays that comply with ICH Q5A (1) and related regulatory guidelines,” …
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Reviewing the Importance of Biosimilarity and Interchangeability
Analytical studies for determining biological activity may involve in-vitro assays, cell-based assays, or other relevant biological assays depending on the mechanism of action of the drug, Stamm remar…
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
SPR has also shown greater precision and reproducibility than the traditional cell-based assays such as ADCC and CDC.
SPR applications are not only limited to ligand–receptor interacti…
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Ensuring Viral Safety of Viral Vaccines and Vectors
Reverse transcriptase enzyme activity within the retrovirus protein core can be detected using PCR-based reverse transcriptase (PBRT) assays, also called product enhanced reverse transcriptase (PERT) …
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Putting Viral Clearance Capabilities to the Test
“Pre-tests like cytotoxicity and interference assays are essential to prove the validity of the assays used for viral quantification,” he explains. “The product- and step-specific adjustment of virus …
Article
Establishing Acceptance Criteria for Analytical Methods
Knowing how method performance impacts out-of-specification rates may improve quality risk management and product knowledge.
By Thomas A. Little, PhD
To control the consistency and quality o…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
Transgene-specific qPCR assays and a normalizer qPCR assay targeting a host genome region are usually applied. The characterization, focused on the integrity and consistency of the expression construc…
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HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Many of the recommended protein characterization assays are based on liquid chromatography methods such as ion exchange chromatography (IEC) for charge heterogeneity analysis, size exclusion chromatog…