June 02, 2023
Cover Story
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Hope is on the horizon as novel solutions and improvements aimed at benefitting the drug development process with the right framework are coming to the fore.
June 02, 2023
Development
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New fields are being explored to bring novel antibody candidates to the pipeline.
June 02, 2023
Development
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Compliance with GMP standards remains an integral focus in bulk mAb manufacturing.
June 01, 2023
Manufacturing
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Scaling cell therapy production workflows requires the establishment of closed, automated steps.
June 01, 2023
Analytics
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Analytical characterization of biosimilars plays a crucial role in a successful path to regulatory approval.
June 01, 2023
Outsourcing
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Contract testing services demonstrate a major increase in the speed and efficiency of testing using new testing methods and technologies.
June 01, 2023
Regulatory Beat
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An increase in applications for gene therapies is putting stress on FDA’s resources.
June 01, 2023
Manufacturing
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Third-party contract packaging service providers can help save time and money.
June 01, 2023
From the Editor
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Vaccine nationalism strengthens viruses and poses deadly risks for all involved.
June 01, 2023
Upstream Processing
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Media developers and vector manufacturers face a combination of challenges and opportunities.
June 01, 2023
Ask The Expert
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A contamination control strategy should provide an overview of how contamination and containment practices work together to ensure product quality and patient safety, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.
June 01, 2023
From the CEO
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COVID-19 has raised the specter of pandemic planning and the question of what can be done now to prevent future disaster.