Search results for " system"
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Q&As with Industry Leaders
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Adopting Single-Use Systems
Parrish Galliher, Chief Technology Officer Upstream at Cytiva
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
mAbs are also extremely costly, and biologic versions are needed to maintain functioning healthcare systems, according to Theodor Dingermann, a professor and director of the Department of Pharmaceutic…
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Q&A with Industry Leaders: Rita Peters
This trend continued at Interphex 2014 with the introduction of equipment and systems targeting biologics manufacturing.
In other developments, mergers, acquisitions, and supplier consolidation co…
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Manufacturers Struggle with Breakthrough Drug Development
For the long term, FDA would like to see companies adopt innovative manufacturing strategies that can accelerate quality production, such as continuous manufacturing systems. Agency officials note tha…
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Design of Experiments for Analytical Method Development and Validation
A systematic approach for using DOE for analytical method development and validation is discussed in this paper and was written in line with the International Conference of Harmonization (ICH) Q2(R1),…
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Early Communication with Regulators is Essential for SMEs
Understanding the route to drug approval
“From a survey we did in 2011, we found that a lot of SMEs lack personnel with experience of bringing products through the regulatory system. As a result, …
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Implementing QbD in Sterile Manufacturing
They include the process performance as well as the applied systems and the environment, for example, optimized and reduced lyophilization process cycles.
Based on various studies, differing…
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Trends in Downstream Bioprocessing
• Expression systems are producing 5 times what they were 10 years ago.
• Current downstream/purification areas were not designed to handle this increase in production.
• Buffer capacity, colu…
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FDA Seeks Metrics to Define Drug Quality
To move more breakthrough drugs quickly through the approval process, pharmaceutical and biotech companies need to establish high quality production systems early in development. These imperatives put…
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Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
Report from the Lanzarote meeting May 13th – 17th, 2013
Yet another well-attended and successful Plasma Product Biotechnology (PPB) meeting has been held. The meeting focu…