Search results for " protein" in Articles / App Notes
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Will the facility be manufacturing monoclonal antibodies, recombinant proteins, vaccines, antibody-drug conjugates, or fragment antibodies? Also, will the products be mammalian cell-derived or microbi…
Article
Your Reliable Downstream Bioprocessing. Our Proven AxiChrom Columns
The goal for biopharmaceutical manufacturers is to develop a process that will deliver material for clinical trials quickly and smoothly, achieve success in these trials, and scale up to commercial …
Article
Updated Ion Exchange Chromatography (IEX) Handbook
The ion exchange chromatography handbook has been updated to include the expanding range of Capto chromatography media for lab- and large-scale protein purification. The update brings Sepharose and …
Article
Fed-batch supplements to boost cell culture performance
To increase the yield of a target protein, fed-batch culture is often employed in biomanufacturing processes. This application note demonstrates the enhanced performance of commonly used cell lines …
Article
Antibody Purification Handbook
The use of recombinant technology opens up the potential to create an infinite number of combinations between immunoglobulins, immunoglobulin fragments, tags and selected proteins, further manipulatin…
Article
GMP Challenges for Advanced Therapy Medicinal Products
56: Application of Phase-Appropriate Quality Systems and CGMP for the Development of Therapeutic Protein Drug Substance (Bethesda, US, 2012).
About the author:
Sean Milmo is a freelance write…
Article
Best Practices in Qualification of Single-Use Systems
Culter, Protein Purification Protocols, Second Edition (Humana Press, 2004).
14. F. Jameel and S. Hershenson, Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals (W…
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Selecting a Comprehensive Bioburden Reduction Plan
Considerations such as membrane porosity, charge, or protein binding may also influence the selection process.
Hutchinson: Undoubtedly, understanding the organisms endemic within the facility play…
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
This structure replaces specific divisions for monoclonal antibodies and for other proteins staffed by more specialized reviewers. The change should help OBP manage its workload more effectively as bi…
Article
USP Publishes Monoclonal Antibody Guidelines
… other related molecules, such as IgM or other isotype antibodies, antibody fragments, and Fc-fusion proteins. When the active substance is a conjugated antibody, such tests can be performed on the p…