Search results for " industry" in Articles / App Notes
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FDA Provides Guidance on Bispecific Antibody Development Programs
FDA published final guidance on May 24, 2021 to provide industry and stakeholders with recommendations for the development of bispecific antibodies including recommendations for regulatory, quality, n…
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Future Downstream Process Development Solutions for Advanced Therapies
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Q&As with Industry Leaders
mRNA manufacturing strategies
Manufacturing of viral vectors
Purification of plasmids
Oligonucleotide therapeutics
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Cell Culture Media Considerations and Optimization for Improved Titers and Protein Quality
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View our Cell Culture Media and Feeds
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Akron Bio Will Install a Cytiva FlexFactory to Manufacture Plasmid DNA
“With the accelerated growth of the biotechnology industry, companies must choose technologies and solutions that can quickly scale to meet future needs. Cytiva’s FlexFactory provides the speed and fl…
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Innovations in Cell Culture: Manufacturing the Future
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“Innovations in Cell Culture” is a new virtual series from Cytiva, where we will explore and discuss the needs of the biopharma industry with a panel of industry …
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Cytiva Invests $500 Million Over 5 Years to Expand Global Capacity
The company will also hire nearly 1000 personnel in key areas as part of its strategy to support long-term growth in the biotechnology industry.
The investment will include new manufacturing lines …
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Good Manufacturing Practices: Challenges with Compliance
The industry has a good understanding of the importance and need for operating in accordance with CGMPs. The challenges lie in how a sponsor’s approach may be interpreted by FDA in meeting the GMP reg…
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Gene Therapies Push Viral Vector Production
“For this, we also should not forget Industry 4.0 and the use of data analytics and machine learning within biopharma (such as multivariate data analysis). This will influence the production of AAV an…
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The Need for Advanced Process Modeling for New Therapeutic Biologics
Further, the industry lacks “user-friendly tools” and clear workflows for setting up specific process models, and existing process control systems do not implement model-based approaches (2).
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A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
Combination drug-devices
BioPharm: What challenges must the industry resolve in protecting IP for combination therapies (drug/device)?
Royle (Taylor Wessing): Drug/device manufacturers suffe…