Search results for " development"
Article
Predicting Progress in Protein Aggregation
As the development of biologic drugs based on antibodies and other protein/peptide molecules continues apace, the control and prevention of aggregation during manufacturing, downstream processing, for…
Article
Using Digital Twins to Model Process Chromatography
By Jennifer Markarian
A digital twin is a model of a process that allows process development experiments to be run in silico—on a computer—rather than on actual lab or manufacturing equipment. Alt…
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Strategizing for Rapid Changeovers in Biologics Manufacturing
Ribault also asserts that it is important to look across the entire value chain and consider how to ensure the interface between process development and manufacturing works well; another consideration…
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Methods Accelerate Biosimilar Analysis
As the foundation in the development of biosimilars is the analytical strategy, this paper reviews effective analytical methodologies available to perform in-depth characterization of both innovator a…
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The Outlook for CMO Outsourcing in 2019
Most innovator drug companies continue to retain manufacturing and development of their prospective blockbusters in-house.
The financial outlook for CMOs is solid, with growth in revenue tracki…
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Improving Process-Scale Chromatography
The development of new resin chemistries including enhancements to Protein A for monoclonal antibody (mAb) capture, increasing use of automation, implementation of single-use technologies, and explora…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
It typically spans the following five areas:
• Raw materials (RM)
• New process/product development (PD)
• Manufacturing process
• Quality system (Q…
Article
Innovative Therapies Require Modern Manufacturing Systems
At the same time, though, the development of such innovative and targeted therapies heightens the importance of establishing production systems and processes capable of fast scale-up of high-quality c…
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GMP Challenges for Advanced Therapy Medicinal Products
Much of the development work on ATMPs is carried out by academic scientists and clinicians attached to hospitals of universities and other research institutes. They lack the regulatory expertise and r…
Article
CMOs Continue to Improve Overall Biomanufacturing Performance
One such factor is better process development, cited by 81.8% of CMO respondents as contributing to improved biomanufacturing performance, up from two-thirds of respondents in 2014.
This is …