BioPharm International-07-01-2018

July 02, 2018

Knowing and addressing regulatory expectations early on can avoid unexpected delays later, says Siegfried Schmitt, principal consultant at PAREXEL.

July 01, 2018

This article highlights 15 years of changes in biopharmaceutical manufacturing.

July 01, 2018

After 30 years of biologic-drug advances, the industry and patients still have a lot to learn.

July 01, 2018

Biopharma companies can balance competing demands from patients, investors, and regulators by keeping a focus on science.

July 01, 2018

Modern technologies, including Industry 4.0 and the Industrial Internet of Things, offer opportunities to increase biopharmaceutical manufacturing efficiency.

July 01, 2018

FDA seeks more efficient testing to spur development of less costly biotech therapies.

July 01, 2018

Process analytical technology tools have enabled manufacturers to monitor and control their production processes.

July 01, 2018

Quality experts share insights on what the future may hold regarding regulatory quality requirements for biopharmaceuticals.

July 01, 2018

BioPharm International asked an FDA spokesperson how the agency plans on handling these issues in the future.

July 01, 2018

Increasing demand for biologics is driving the need for innovation in bioprocessing.

July 01, 2018

Late-stage and commercial biomanufacturing pose a challenge to cell-culture processing.

July 01, 2018

Biosimilars and biobetters face developmental challenges to achieving commercialization.

July 01, 2018

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.

July 01, 2018

Click the title above to open the BioPharm International July 2018 issue in an interactive PDF format.