Search results for " Biopharm"
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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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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…
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Genetic Vaccine Platforms Demonstrate Their Potential
“The majority of these vaccines may not even require biosafety measures during production at all, merely the same techniques as those used for other biopharmaceutical products,” notes Becker. As such,…
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The Need for Advanced Process Modeling for New Therapeutic Biologics
Types of modeling approaches
There are many different types of models used in the development of a new process for a novel therapeutic, says Andrew Sinclair, managing director, Biopharm Services, …
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Leveraging Computational Models of Glycosylation for Biopharma QA
… by work that found considerable glycosylation variation among different commercial lots of the same biopharmaceutical product (4).
Biopharmaceutical glycosylation variability is determined by ma…
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A Plastic Pipeline for Commercial Bioprocessing?
Pressure to get drugs to market faster, the smaller batch sizes characteristic of targeted therapies, and the comfort level biopharma companies and contract manufacturing organizations (CMOs) have wit…
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Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
These new “rapid” dyes are becoming increasingly popular in many biopharma glycoprofiling workflows due to their inclusion in commercial sample preparation kits (e.g., GlycoWorks, Waters and GlycoPrep…
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Biopharma Seeks Balance
Peters
A biopharma company answers to multiple masters: the patient who depends on effective drug products for health or survival; regulatory authorities that monitor quality; …
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Challenges in Cell Harvesting Prompt Enhancements
The past decade has seen the biopharmaceutical industry move toward significantly higher titers, and, as a result, higher cell densities. Biomanufacturers have been shifting from large stainless-steel…
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Understanding Validation and Technical Transfer, Part 2
While the example is not related to biopharmaceutical manufacture, it demonstrates various points to consider related to the inputs, the processing system, and the outputs that can be applied to bioph…