Search results for " costs"
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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
In this study, the authors evaluated different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture. By raising the pH or by adding surfactants, the fe…
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Biopharma Moves to Integrated, Single-Use, Downstream Processing
Suppliers see challenges to the adoption of single-use technologies for downstream processing as opportunities.
A lack of single-use technologies
The greatest barrier for adoption …
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Challenges in Analytical Method Development and Validation
…sitivity, range, robustness/maintenance, as well as speed and throughput capacity, but possibly also costs and ease of operations) should be established early and re-evaluated as needed throughout pr…
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Biopharma Takes a Nervous Glance Over Its Shoulder
According to the study findings, executives feel that US payers increasingly are not adequately valuing new treatments and are too focused on reducing prescription drug costs. This short-term approach…
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Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
New approaches to vaccine production are targeting rapid supply for pandemic situations and broadly effective therapeutic treatments.
Following the 2009 outbreak of the H1N1 pandem…
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Q&A with Industry Leader Konstantin Konstantinov, Genzyme Vice-President
…turers to move to continuous processing, because it allows for more efficient operations and reduced costs.
These same drivers are present in biotechnology as well. In addition, continuous…
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Brazil Emerges as Global Biopharm Collaborator
With the economy still under control and regulation equivalent to those of developed nations, challenges now lie within high taxes and costs as well as strict price controls, according to Mussolini. S…
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Determining Criticality, Part Two: DoE and Data-Driven Criticality
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
T…