Search results for " drug"
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The Smart Benefit of Digital Systems in Preclinical Studies
Here, a closer look at smart tools highlights how they support enhanced and intelligent data gathering as well as analysis in drug discovery and preclinical studies.
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Developing a Robust Bioprocess Using Mechanistic Models
The robustness of the manufacturing process has to be validated in order to bring a new biological drug to market.
Regulatory agencies such as the Food and Drug Administration (FDA) and Euro…
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Cell-free Expression Systems Pose Cell Culture Alternative
Companies, such as Sutro Biopharma, a US-based clinical-stage drug discovery, development, and manufacturing company, for instance, are already making microbial cell-free extracts and products at scal…
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Assessing Manufacturing Process Robustness
ICH, Q11 Development and Manufacture of Drug Substance, Step 4 version (2012)
5. ICH, Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management, Step 4 vers…
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Technology Innovations Improve Process Chromatography Performance
Any percentage of improvement in downstream recovery can contribute to improving the ultimate process yield for drug product of the target biologic,” he adds.
Deorkar also notes that there is a la…
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Mechanistic Modeling: Current Advantages and Future Opportunities in Biopharmaceutical Process Development
A systematic way of relating material attributes and process parameters to drug product quality attributes should be self-understood. Purely data-driven approaches then have a hard time explaining why…
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Improving Upstream Predictability
This environment, in turn, results in more consistent drug product with an improved safety profile,” says Verlenden. Single-use bioreactors at commercial scale (i.e., 2000 L) have become standard, he …
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Flexible Facilities for Viral Vector Manufacturing
This is quite relevant in the gene therapy segment as many gene therapies are qualifying for orphan drug status or fast track designation status, shortening the drug development timeline from seven to…
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The Need for Advanced Process Modeling for New Therapeutic Biologics
The modeling approach can also bring early consideration to the regulatory aspects of drug development and future commercialization, allowing process developers to troubleshoot what may be regulatory …
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Four Steps Toward End-to-End Connected Manufacturing
Continuous biomanufacturing is a key step toward promoting drug quality and improving manufacturing productivity, leading to lower drug prices.
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