Search results for " market" in Articles / App Notes
Article
Host-Cell Protein Measurement and Control
Regulatory agencies from other countries and emerging markets may have their own wording on HCP control, but it is generally accepted that a sensitive, validated method is required to monitor residual…
Article
Use of Multivariate Data Analysis in Bioprocessing
…r and their biosimilar version, the regulatory authorities may consider the approval of the drug for market authorization with minimal clinical studies data.
A quantitative approach has been presen…
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Ensuring the Quality of Biologicals
…to establish the comparability of a biosimilar to an original biological product in the context of a marketing authorization application.
Even though users of the Ph. Eur. are supportive of the e…
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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 …