Search results for " industry 4.0"
Article
Using Digital Twins to Model Process Chromatography
Mechanistic models provide process understanding for developing robust manufacturing processes and for scale up and tech transfer.
By Jennifer Markarian
A digital twin is a model of a proces…
Article
Assessing Manufacturing Process Robustness
A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.
By: Ajay Pazhayattil, Sanjay Sharma, Amol Galande, Marzen…
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FDA Provides Guidance on Bispecific Antibody Development Programs
The final guidance document provides recommendations for regulatory, quality, nonclinical, and clinical considerations for bispecific antibody development programs.
FDA published final guidance …
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Future Downstream Process Development Solutions for Advanced Therapies
downstream
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Peter Guterstam, PhD, Product Manager of Next Generation Resins & Technologies at Cytiva, provides insight into solutions for ad…
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Cell Culture Media Considerations and Optimization for Improved Titers and Protein Quality
Peggy Lio, Cytiva
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Peggy Lio, Senior Director of Global Cell Culture Services at Cytiva, explores the evolution of b…
Article
Akron Bio Will Install a Cytiva FlexFactory to Manufacture Plasmid DNA
Cytiva will provide the first FlexFactory to be used in the manufacture of pDNA to Akron Bio.
Cytiva will provide its FlexFactory, a flexible, single-use platform, to enable Akron Biotech to m…
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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 …
Article
Cytiva Invests $500 Million Over 5 Years to Expand Global Capacity
The investment will include new manufacturing lines and increased automation to deliver additional manufacturing capacity.
On Sept. 13, 2020, Cytiva, announced that it is investing $500 million o…
Article
Good Manufacturing Practices: Challenges with Compliance
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The complexity of biologics and the use of new technologies present challenges for complying with CGMPs.
By Lauren Lavelle
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Article
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…