Search results for " cost" in Articles / App Notes
Article
Drug Discovery and Development in India
As a result, Indian pharmaceutical companies have begun to move their operations outside of the country, despite the potentially higher cost. Lupin Pharmaceuticals has set up two research and developm…
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Vaccine Development and Production Challenges Manufacturers
Doctors Without Borders complained that price cuts proposed by Pfizer and GlaxoSmithKline (GSK) were inadequate; manufacturers countered that they were providing their products below cost (1). The dis…
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SEC in the Modern Downstream Purification Process
The low-cost/low-complexity use of SEC resins in single-use technologies would be ideal to alleviate growing economic concerns and would reduce costs by eliminating some of the validation expenses ass…
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Ligand-Binding Assays and the Determination of Biosimilarity
…homogenous no-wash platforms aid in assay transferability, reproducibility, scalability, and overall cost reduction. They are also very robust and meet development criteria, which is equally importan…
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Challenges of Protein Aggregation During Purification
“In particular, resolubilization of insoluble aggregates typically requires extra process steps and can both be very costly and compromising on the overall process yield,” adds Jagschies.
Changing…
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Evaluating Design Margin, Edge of Failure and Process
PPM can further be converted into cost or other metrics of interest.
Conclusion
Modern drug development and ICH standards encourage design space generation in new product development. It is a …
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Single-Use and Continuous Processing Technologies Change Facility Design
Liquids can be pushed around in bags, thus removing the need for pipes and pumps, simplifying the facility and reducing engineering costs, for example. With stainless steel, duplicate equipment is nee…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
An approach for establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.
A critical quality attribute (CQA) has been defined as “a physical, chemical, …
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Concentrating Feed—an Applicable Approach to Improve Antibody Production
Feed-volume reduction can also reduce the cost of consumables, such as disposable bags and medium storage space. Because the feed dilutes the culture and reduces product concentration, the use of lowe…
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Biopharma Moves to Integrated, Single-Use, Downstream Processing
For those technologies that are available, she adds, scalability, performance, and cost are typical limitations.
Chromatography is the last purification unit operation to move to disposability and…