BioPharm International
March 02, 2019
Features
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Jessica Rousset, chief operating officer, CURE Pharmaceutical, highlights some key regulatory considerations developers should keep in mind when approaching alternative dosage forms.
March 01, 2019
Features
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In light of recent FDA guidance on data integrity, the challenges and benefits of using the public cloud to deploy and use data management software are discussed.
March 01, 2019
Global News
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Technology vendors are strengthening their positions in China as the nation emphasizes self-sufficiency in research, development, and manufacturing.
March 01, 2019
Perspectives on Outsourcing
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Single-use systems can be a cost savings for CMOs, and these savings can be passed on to clients and, ultimately, to patients.
March 01, 2019
Regulatory Beat
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FDA expects more than 200 investigational new drug applications for cell and gene therapies by 2020, causing the agency to strengthen its regulatory program.
March 01, 2019
Cover Story
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Optimizing the patient experience and technological advances can positively impact adherence.
March 01, 2019
Features
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Both empty and filled syringes must pass a range of tests to meet quality standards for biopharmaceutical drugs.
March 01, 2019
Ask the Expert
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Simplification is crucial to maintain data integrity, according to Siegfried Schmitt, PhD, vice-president, technical at PAREXEL Consulting.
March 01, 2019
From the Editor
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Do patients get what they pay for when they demand cheaper drugs?
March 01, 2019
Features
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A properly designed validation program will detect variation and ensure control based on process risk.
March 01, 2019
Features
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A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an advancement over the traditional steady-state analysis of biomolecules.
March 01, 2019
Features
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A look at recent investments by contract manufacturers to increase single-use bioreactor capacity.
March 01, 2019
Features
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Downstream process equipment for mAbs manufacturing must be designed to fit technology developments in upstream processes.
March 01, 2019
Features
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As automation in biomanufacturing becomes more important, so does the need to integrate process data.
March 01, 2019
Issue PDF
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Click the title above to open the BioPharm International March 2019 issue in an interactive PDF format.