Search results for "chromatography"
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Figure 1: The total ion current (TIC) chromatogram obtained from on-line reverse phase-high-performance liquid chromatography with electrospray mass spectrometry (RP-HPLC/ES-MS) analysis of a monoclon…
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…
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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…
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Best Practices in Adopting Single-Use Systems
Key considerations for implementing single-use components or platforms when moving from research to process development.
The adoption of single-use systems in biopharmaceutical production or…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
For example, the parameters of the cation- and anion-exchange chromatography processes are expected to have a high impact on impurities because they are designed to remove impurities of different ioni…
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Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
Report from the Lanzarote meeting May 13th – 17th, 2013
Yet another well-attended and successful Plasma Product Biotechnology (PPB) meeting has been held. The meeting focu…
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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…