Search results for " industry"
Article
Setting Up Bioprocessing Systems for Digital Transformation
By Feliza Mirasol
The advancement of digitalization technologies is transforming manufacturing processes and operations in the biopharmaceutical industry. Bioprocessing is no exception, as the ind…
Article
Regulatory Requirements for Safe and Efficient Biologic Drug Development
Two examples are the International Site for Pharmaceutical Engineers and the Parenteral Drug Association, which have a lot of different guidelines or technical reports that are developed by groups of …
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Biosimilar Quality Requirements
…he guidance Considerations in Demonstrating Interchangeability with a Reference Product Guidance for Industry (2).
Congress created an approval pathway in the Biologics Price Competition and Inno…
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Addressing the Complex Nature of Downstream Processing with QbD
The industry has been slowly adopting the QbD approach, but with the boom in the biopharma industry, how have these QbD principles fit into the complex nature of biologics? According to Gunnar Malmqui…
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Jefferson Institute for Bioprocessing Opens Near Philadelphia, PA
In addition to open enrollment courses, JIB also offers customized training to meet industry needs with specialized courses developed with companies and delivered either at JIB or the company site. JI…
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Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
However, the industry is also exploring new approaches that would move testing and monitoring of CQAs out of the lab.
As part of the BioPhorum Operations Group’s (BPOG’s) Biomanufacturing Technol…
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Single-Use for Downstream Chromatography: Benefit or Hindrance?
Hindrance or help?
Many disposable chromatography columns meet cGMP and industry standards, and also offer reproducibility, scalability, speed, ease-of-use, and operational safety.
However, chr…
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Leveraging Computational Models of Glycosylation for Biopharma QA
Although the deployment of statistical models in industry is increasing at an accelerated pace (49), the use of mechanistic glycosylation models remains to be widespread. This disparity may arise from…
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Understanding Validation and Technical Transfer, Part I
…Canada, Switzerland, Brazil, China, and the Republic of Korea, and representatives of pharmaceutical industry organizations, has published a series of documents that, among other things, relate to pr…
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Biopharmaceutical Market in Asia: Q&A with Günter Jagschies, Strategic Customer Relations Leader, Cytiva
Korea, Japan, and Singapore, in particular, have a well-established biopharma industry with development and manufacturing capabilities that compete with businesses in North America or Europe at eye le…