Search results for " purity"
Article
A Q&A With Phil Lester, co-organizer of the HTPD Conference
The goal is to purify the target protein to the highest purity and yield, using the most efficient workflows and fewest resources. We have six teams competing—they began work in January and will finis…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
“This characterization should include the determination of physicochemical and immunochemical properties, biological activity, purity, impurities, and quantity of the mAb, in line with ICH Q6B guideli…
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Concentrating Feed—an Applicable Approach to Improve Antibody Production
There were no changes in antibody monomer percentages and protein purity with addition of P188 (data not shown).
Antibody production in 5000-L bioreactor using concentrated feed m…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
A…
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Comparing Protein A Resins for Monoclonal Antibody Purification
Protein A is the affinity chromatography ligand of choice for the first antibody capture step, because its high selectivity gives excellent purity (typically > 99%) and high yields. Furthermore, Prote…
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Elucidating Biosimilars Characterization
…uivalence to show that their medicine contains the same active pharmaceutical ingredient at the same purity and same dose and with the same administration route as the innovator product.
Applicat…
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Biosimilars Development and Supply: How Complex Can the Process Be?
…uch precision involves investing in quality processes to consistently achieve high levels of product purity and manufacturing success through robust manufacturing processes.
The complexity of …
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Regulatory Challenges in the QbD Paradigm
…cal studies to demonstrate that the change has no adverse effect on the identity, strength, quality, purity, or potency of the product. Reporting of the change must be in accordance with regulation o…
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Automated Concentration and Diafiltration of Multiple siRNA Samples
After screening of collected fractions, the final pool is analyzed for purity by RP-HPLC and quantified using optical density at 260 nm. Typical results for a 200 μmol synthesis are volumes of 0.6–2 L…
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PDA's Technical Report for Biotech Cleaning Validation
Any change in the validated state of a cleaning process might detract from the quality, safety, and purity of manufactured products. Tools for validation maintenance covered in Technical Report No. 49…