Search results for " manufacturing" in Articles / App Notes
Article
Exotoxin Clearance from mAb Samples in a Two-Step Chromatography Process
A heat-stable exotoxin can remain as a contaminant of a drug substance throughout the whole manufacturing process, with the risk of adversely affecting patients’ health. One such toxin is cereulide …
Article
Techniques for Improving Process Development for Exosome-Derived Therapeutics
What are the main process development and manufacturing challenges for this class of compounds to be successful?
The first challenge relates to the heterogeneity of exosomes. Because exosomes are …
Article
QbD Improves Cell-Culture Process Control
Mammalian cells are most frequently used as the hosts for manufacturing complex biopharmaceuticals, and cultivation of these host cells is a key factor in the production of biotherapeutics. The cultiv…
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Development and Future of Protein A Chromatography Technology: Q&A with Jonathan Royce, Business Leader Chromatography Resins, Cytiva
…d systems can be improved without costly capital expenditures, making more efficient use of existing manufacturing footprint. Alternatively, smaller resin volumes could be used to achieve a given mas…
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Current Innovations and Practices To Address Microbial Contamination in Downstream Bioprocessing
Improved ways of working in the manufacturing facility have been facilitated by supplier developments in automation, closed systems, and single-use solutions.
Learn more on how to address bioburde…
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Impact of Media Components on CQAs of Monoclonal Antibodies
Factors that play a role in media design originate from three major sources, namely the attributes of the product under consideration, the cell line that is being used for protein production, and the …
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How to Address Bioburden Challenges: Insights and Tips
Bioburden control is an area of serious concern for anyone making mAbs or other biologicals. Manufacturers’ efforts to avoid microbial contamination are today being complemented by developments from…
Article
Managing Risk in Biomanufacturing
This white paper focuses on how commercial, manufacturing, and supply aspects can be managed more successfully to mitigate risk.
Download white paper
Article
Improvements in Protein A Chromatography
These devices are not currently practical for large scale manufacturing, but may represent a format for future improvements in Protein A productivity.
Number of cycles on the Protein A column are …
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Critical Quality Attributes Challenge Biologics Development
…s an evolving process from the discovery phase to clinical stages to product approval and commercial manufacturing. In the early discovery and development stages, criticality determination of each pr…