Search results for "column" in Articles / App Notes
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
“This method provides absolute determination of molar mass, independently of SEC column calibration, so we can be certain of the identification of eluting species.” Larger, irreversible aggregates of …
Article
Quality by Design and Extractable and Leachable Testing
If the component has a new extractable due to lack of manufacturing consistency, it may not be picked up during leachable assessment if the wrong column or method is used. A supplier’s pharmaceutical …
Article
Technologies and Practices Must Evolve to Meet Demand
Cell-culture products, bioreactors, filtration, chromatography columns, and centrifugation received “excellent” grades from more than 24% of those surveyed. More than 10% of the respondents, however, …
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
Antibody titer was measured using high-performance liquid chromatography (HPLC) (Waters Corporation) equipped with a protein A column (Applied Biosystems). The protein charge profile was analyzed by i…
Article
Challenges in Analytical Method Development and Validation
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals.
The manufacture of biopharmaceuticals presents …
Article
Q&A with Industry Leader Konstantin Konstantinov, Genzyme Vice-President
But now several companies, including Cytiva, are making unit operations for continuous chromatography based on switching columns. So we’re beginning to see a movement toward integrated up and downstre…
Article
Outsourcing Trends in Biopharmaceutical Manufacturing
From expertly packing chromatography columns, to providing higher-quality liquid media and buffers at large-scale, suppliers with technical competence are taking on some of the industry’s most challen…
Article
2014 Manufacturing Trends and Outlook
Better filtration, chromatography columns, automation, and process analytical technologies also were identified as ways to improve manufacturing efficiencies.
an Alternative:
Outsourced M…
Article
Evolution of the Monoclonal Antibody Purification Platform
The authors discuss the evolution of the purification platform for manufacturing of mAb therapeutics.
Monoclonal antibodies (mAb) increasingly form the majority share of the product pipeline…
Article
QbD and PAT in Upstream and Downstream Processing
For example, a typical elution in chromatography column may be 30–60 minutes. Our ability to measure and then take action, therefore, is quite challenged if the assay is not a real-time assay (such as…