May 02, 2023
Cover Story
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New therapeutic opportunities are offering significant promise for the bio/pharma industry and patients.
May 02, 2023
Development
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The development of CAR-T therapies for solid tumor cancers presents a myriad of challenges.
May 02, 2023
Upstream Processing
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It is crucial to examine the context in which single-use waste is viewed.
May 01, 2023
Downstream Processing
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Optimization strategies that leverage advanced technologies are essential for maximizing yield and quality.
May 01, 2023
Analytics
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Avoiding missteps in data integrity is contingent on the development of a holistic data integrity approach.
May 01, 2023
Quality/Regulations
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Guidance for GMP manufacture of emerging therapies has evolved to accommodate innovation and the broader spectrum of products in development, but greater harmonization is still needed.
May 01, 2023
Regulatory Beat
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FDA is encouraging sponsors to conduct studies and file applications for full approval of products authorized by Emergency Use Authorizations.
May 01, 2023
Ask The Expert
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The concept of quality culture and how to enforce it are being debated by regulators and industry, says Siegfried Schmitt, vice president, Technical at Parexel.
May 01, 2023
Outsourcing
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Preclinical studies specifically benefit from the “smart” drug development trend through deeper data access and analysis.
May 01, 2023
From the Editor
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INTERPHEX was back in full swing with Keynote sessions highlighting cutting-edge technologies that are setting the stage for the bio/pharma industry’s future.
May 01, 2023
From the CEO
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The engine that drives pharmaceuticals forward, its workforce, is now very low on fuel.