Search results for " market"
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Tackling Analytical Method Development for ADCs
In addition, as more products make it into the clinic and then into the market, Jacobson expects that regulators will become more familiar, and more comfortable, with the ability of current analytical…
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FDA Approves First Biosimilar
As a result of these savings, “Biosimilars are likely to create greater competition in the medical marketplace,” said Christl in an FDA Consumer update, released the same day as the Zarxio approval no…
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Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
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About the Authors
Sara Ullsten, PhD is bioprocess project manager; Eva Lindskog, PhD, is upstream marketing segment leader; Eva Blanck is research engineer; Shujian Yi, PhD, is senior polym…
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Securing the Single-Use Supply Chain
Consequently, an SUS is a critical part of drug substance manufacturing, and there is a greater need to understand and secure the sourcing of these systems,” says Roman Rodriguez, global market develo…
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Trends in Single-use Bioreactors
However, this is changing and there are reliable options on the market today. Fundamentally, single-use bioreactors are quite reliable. It is still crucial for the end-user to carefully select the pro…
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Viral Clearance Challenges in Bioprocessing
…ages of the product lifecycle, from before the clinical phase through more comprehensive studies for marketing authorization. In the first case, a fully validated production process is typically not …
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High-Throughput Process Development in an Historical Environment
Several new equipment and innovations were introduced to the market, such as micro bioreactors in the 10-15 ml scale, controlled by an automated workstation. As an example of their utilization, Chris …
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Continued Process Verification for Biopharma Manufacturing
…ariation and, therefore, improve process robustness and increase assurance of reliable supply to the market. Adopting or building on an existing system of monitoring manufacturing process performance…
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Challenges of Protein Aggregation During Purification
The technology was developed at the University of Colorado and is currently marketed by BaroFold under the name Pressure Enabled Protein Manufacturing (PreEMT) technology. In January 2013 and November…
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EMA Invites Comments on New Guidance for Vaccine Development
…H1N1) pandemic, requests for scientific advice received from vaccine developers and applications for marketing authorization.
The guidance provided applies to vaccines for which ample regulatory …