Search results for " process" in Articles / App Notes
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
Often in fed-batch processes, the feed volume can be more than 1000 L for a 5000-L bioreactor with 30 to 40% (v/v) feed. To alleviate workload in media preparation and simplify the manufacturing proce…
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Design of Experiments for Analytical Method Development and Validation
Design of experiments (DOE) is a well-proven characterization approach within product and process development and a key aspect of quality by design. Recently, more attention has been placed on applyin…
Article
Report from the 6th International HTPD Conference
The HTPD conference series started as a joint initiative by Cytiva and Genentech in 2010 at a time when high-throughput process development was in its early days. HTPD was mainly limited to 96-well pl…
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Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
Another driver pushing developers to consider suspension cell lines is the desire to move away from serum for biosafety, cost, supply, and processing needs. However, as it will be explained later, the…
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Innovative Chromatography Resins Can Improve Purity and Quality
With ongoing efforts to increase monoclonal antibody (mAb) productivity in large-scale biomanufacturing, biomanufacturers continuously seek advancements in downstream processing technologies, with dow…
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Regulatory Requirements for Safe and Efficient Biologic Drug Development
…te the regulatory approval path
9:44 - The impact of filing accelerated review applications on process development
11:41 - What quality teams should do to ensure quality standards are mai…
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Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
Problems can result when changes are made to manufacturing processes. Complexity—in particular, determining which product attributes are most crucial to product quality and patient safety—makes it cha…
Article
What’s New in Upstream Technologies
The system features a modular, scalable, fixed-bed bioreactor for enhanced upstream processing of viral products, including viral vaccines, viral vectors, and oncolytic viruses. The low-footprint inte…
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Automation Trend in Fill/Finish Reduces Contamination Risk
By Feliza Mirasol
Aseptic filling is a crucial process in biopharmaceutical manufacturing because it has a potential safety impact on the end user and because aseptic filling is a highly tec…
Article
Preclinical Evaluation of Product Related Impurities and Variants
Often, these processing steps result in formation of certain molecular variants and impurities in addition to the pure GCSF. These include the oxidized, formyl methionine (f-Met), reduced, and aggrega…