Search results for " Elisa"
Article
Ligand-Binding Assays and the Determination of Biosimilarity
LBA detection techniques
There are essentially two general methods for assessing ligand binding: ELISA (enzyme-linked immunosorbent assay)-type assays and kinetic binding assays. Classical ELISA a…
Article
Virus-like Particles as Therapeutic Moieties of the Future
Solution competitive ELISA tracks the correct display of epitopes on VLPs with a neutralizing monoclonal antibody against the respective epitope, which allows real-time monitoring of relative antigeni…
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Development of Purification for Challenging Fc-Fusion Proteins
CHO HCP levels were measured by ELISA method for the quantitation of residual host cell proteins in solution (Cygnus Technologies). Quantitation was achieved by comparing the signal of the sample to h…
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Generating a Fully Processed Antibody
These top four clones were again analyzed for FGE expression using the flow cytometry assay as well as a FGE ELISA method that was performed on cell lysates. The results indicated that one clone (#120…
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Tackling Analytical Method Development for ADCs
Other techniques such as iCE, CGE, ELISA, cytotoxicity and methods for residuals are developed by subject matter experts and optimized for each product. Testing for safety and quality attributes (biob…
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The Development and Application of a Monoclonal Antibody Purification Platform
We measured residual recombinant protein A levels using a sandwich ELISA kit from Repligen (Waltham, MA). Finally, residual total DNA was evaluated by extraction using the DNA extractor kit from Wako …
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PDA's Technical Report for Biotech Cleaning Validation
The authors encourage biotech manufacturers to consult PDA Technical Report No. 49 for a detailed perspective on current practices and issues in biotech cleaning validation.
By Anurag S. Rathore, D…
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Alternative solutions to separate AAV full and empty capsids using anion exchange
And separation results were confirmed by PCR, ELISA, mass photometry, and analytical ultracentrifugation. We show that these AEX approaches are reproducible and can be scaled up.
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Sensitive and Reproducible SPR-Based Concentration and Ligand-Binding Analyses
Surface plasmon resonance (SPR) assays are used across the life cycle of a biopharmaceutical, from target identification, through CQA determination, development, and on-going quality control. This art…
Article
Preclinical Evaluation of Product Related Impurities and Variants
Preclinical Evaluation of Product Related Impurities and Variants
The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the s…