March 2019
Volume 32, No. 3 |
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| COVER STORY |
Felicity Thomas
Optimizing the patient experience and technological advances can positively impact adherence.
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| UPSTREAM PROCESSING |
Feliza Mirasol
A look at recent investments by contract manufacturers to increase single-use bioreactor capacity.
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| DOWNSTREAM PROCESSING |
Feliza Mirasol
Downstream process equipment for mAbs manufacturing must be designed to fit technology developments in upstream processes.
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| BioPharm International March Issue
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| MANUFACTURING |
Feliza Mirasol
As automation in biomanufacturing becomes more important, so does the need to integrate process data.
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| ANALYTICS |
Stuart Ward
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.
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| BIOSIMILARS |
Anurag S. Rathore, Rozaleen Dash
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.
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| QUALITY |
Clifford J. Sachs
A properly designed validation program will detect variation and ensure control based on process risk.
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| OPERATIONS |
Cynthia A. Challener
Both empty and filled syringes must pass a range of tests to meet quality standards for biopharmaceutical drugs.
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| FROM THE EDITOR |
Rita C. Peters
Do patients get what they pay for when they demand cheaper drugs?
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| REGULATORY BEAT |
Jill Wechsler
FDA expects more than 200 investigational new drug applications for cell and gene therapies by 2020, causing the agency to strengthen its regulatory program.
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| PERSPECTIVES ON OUTSOURCING |
Ilene Roizman, Eric Langer
Single-use systems can be a cost savings for CMOs, and these savings can be passed on to clients and, ultimately, to patients.
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| GLOBAL NEWS |
Agnes Shanley
Technology vendors are strengthening their positions in China as the nation emphasizes self-sufficiency in research, development, and manufacturing.
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| ASK THE EXPERT |
Siegfried Schmitt
Simplification is crucial to maintain data integrity, according to Siegfried Schmitt, PhD, vice-president, technical at PAREXEL Consulting.
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| EVENTS |
March 11–13, 2019
March 17–21, 2019
March 18–21, 2019
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