BioPharm International July 2018

July 2018 | Volume 31, Issue 7
BioPharm International July 2018 Issue
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By BioPharm International Editors
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Cover Story
Biopharma companies can balance competing demands from patients, investors, and regulators by keeping a focus on science.
This article highlights 15 years of changes in biopharmaceutical manufacturing.
Biosimilars and biobetters face developmental challenges to achieving commercialization.
Late-stage and commercial biomanufacturing pose a challenge to cell-culture processing.
Increasing demand for biologics is driving the need for innovation in bioprocessing.
BioPharm International asked an FDA spokesperson how the agency plans on handling these issues in the future.
Quality experts share insights on what the future may hold regarding regulatory quality requirements for biopharmaceuticals.
Process analytical technology tools have enabled manufacturers to monitor and control their production processes.
FDA seeks more efficient testing to spur development of less costly biotech therapies.
Modern technologies, including Industry 4.0 and the Industrial Internet of Things, offer opportunities to increase biopharmaceutical manufacturing efficiency.
Safeguarding the know-how behind biopharmaceutical innovation is crucial to the industry’s future, but, in the US, some argue it is becoming increasingly difficult to do.
From the Editor
After 30 years of biologic-drug advances, the industry and patients still have a lot to learn.
Ask the Expert
Knowing and addressing regulatory expectations early on can avoid unexpected delays later, says Siegfried Schmitt, principal consultant at PAREXEL.
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