July 09, 2024
Development
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Weighing development costs/resources and performance benefits is essential.
July 09, 2024
Cover Story
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As the CGT market matures, increased focus lays in securing optimal efficacy while ensuring safety.
July 08, 2024
Quality
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This paper reflects upon the past 15 years of experience in the application of QRM and KM within the pharmaceutical GMP environment.
July 06, 2024
Manufacturing
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The increased demand for biopharmaceutical products is increasing the demand for lyophilization innovations and services.
July 05, 2024
Analytics
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Although advancements in analytical drug substance testing are being made, the increasing diversity of the therapeutic landscape is necessitating further innovation.
July 04, 2024
Outsourcing
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HCPs are major process-related impurities that must be monitored throughout biologics production for clearance.
July 03, 2024
From the CEO
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A greater number of patients with Duchenne muscular dystrophy will be able to be treated after FDA's approval of a gene therapy.
July 02, 2024
Ask the Expert
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Communication and meetings with FDA after receiving a warning letter demonstrates a serious response, says Siegfried Schmitt, vice president, Technical at Parexel.
July 01, 2024
Product Spotlight
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The ROSS Model HSM-405SC-25 Inline High Shear Mixer features a built-in workbench and is designed for production floors that require flexibility.
July 01, 2024
Product Spotlight
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The VIOS family of incubators are known for optimal cell growth conditions and minimal contamination risk.