Search results for " production"
Article
Remote Monitoring and Big Data Advance Upstream Automation
Machine learning and AI capabilities are moving to the production environment, and as mobile equipment gets more advanced and cheaper, facility floor workers are being provided access to augmented rea…
Article
Updating Viral Clearance for New Biologic Modalities
…, they require meticulous filtration, even in more established processes such as monoclonal antibody production.
However, demonstrating viral clearance is even more difficult with the newer bioth…
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Automating the Biomanufacturing Process
Automation has traditionally focused on controlling the manufacturing process throughout production to ensure that product remains identical between batches. Control has been manifested mainly in mini…
Article
The Outlook for CMO Outsourcing in 2019
Figure 1: Biopharmaceutical manufacturing facilities outsourcing no production 2006-2018. (Figure courtesy of the authors).
In 2018, 30% of survey respondents reported no mammalian outsourcing,…
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
Comparative analysis through clinical evaluation is also required for production of the biosimilar product.
Immunogenicity is another important aspect of biosimilarity. Because it is not possible …
Article
Fermentation for the Future
Jan 01, 2015
By Cynthia Challener, PhD
Microorganisms—bacteria and yeast—have been widely used for the production of genetically engineered (recombinant) biopharmaceuticals. Typical examples…
Article
Challenges in Analytical Method Development and Validation
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals.
The manufacture of biopharmaceuticals presents …
Article
Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
As the European Union takes a closer look at its biosimilars guidelines, some key issues are proving difficult to resolve.
The European Union is strengthening its pioneering role in the regulati…
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Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes.
By Susan Haigney
natali_mis/Stock.Adobe.com
Regulators have been en…
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Scaling Up Novel Therapies
As a result, on the bacterial side, developers can now go into production using 100- to 300-L single-use reactors. “You can start working with those technologies at much smaller scales now than was po…