Search results for " control"
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Common Challenges in Cross-Functional Process Development
James is a leading industry consultant with broad chemistry, manufacturing, and controls experience in product development and quality that encompasses early process development to commercial operatio…
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FDA Provides Guidance on Bispecific Antibody Development Programs
This guidance discusses unique aspects for chemistry, manufacturing, and controls (CMC), as well as nonclinical and clinical development programs for bispecific antibodies. Industry and other stakehol…
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Sanitization Opportunities for Protein A Resins
As an alternative, the oxidizing agent peracetic acid (PAA) could be used in the control of such contaminants.
Here, we describe an approach to safely sanitize our new generation bioprocess prote…
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Akron Bio Will Install a Cytiva FlexFactory to Manufacture Plasmid DNA
The FlexFactory, designed for cGMP manufacturing, provides traceability and optimization by combining control, connectivity, automation, and supporting services that accelerate manufacturing, accordin…
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ISPE Releases Cleaning Validation Guide
ISPE has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitioners.
The International Society for Pharmaceutical Engin…
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Simplifying Cell Culture Expansion
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Controlled perfusion in a closed, single-use bioreactor can cut the complexity from your cell culture expansion process, making it possible to go from seed trai…
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Considerations for Improving Outcome in Biopharmaceutical Process Development
For example, things like streamlining operations, optimizing titers and yields, evaluating cell lines and cell culture media, and controlling raw material variability can play a pivotal role in obtain…
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Gene Therapies Push Viral Vector Production
A major challenge remains, however, and that is to control the amount of empty and hence non-infectious particles during manufacturing.
“For this, we also should not forget Industry 4.0 and the…
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Flexible Facilities for Viral Vector Manufacturing
…oubled the site’s laboratory and warehousing capacity for upstream process development and quality control testing of gene therapy products (6). “Logistics and warehousing are vital to the success of…
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Introducing Process Characterization Kit: New Tools for Gaining Deeper Chromatography Process Understanding
With these insights, you can develop a solid control strategy for a robust downstream process.
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