Search results for " purity" in Articles / App Notes
Article
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…
Article
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…
Article
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…
Article
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…
Article
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 …
Article
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…
Article
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…
Article
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…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
The sequence of the polishing steps is also important for both purity and capacity.
ANTIBODY-DRUG CONJUGATES
Numerous antibody drug conjugates (ADCs) are in clinical trials with most of them b…