BioPharm International December 2017

December 2017 | Volume 30, Issue 12
BioPharm International December 2017
Cover Story
Biopharma employees reveal employment objectives, opportunities, and frustrations.
Single-use systems provide replaceable fluid paths.
A technology roadmap aims to drive and consolidate improvements in a process that has remained unchanged for more than 70 years.
A quality-by-design approach that implements PAT offers advantages in upstream cell-culture processing.
A roundtable Q&A with biopharma executives elucidates the challenges posed by single-use bioreactor bags in contributing to extractables and leachables in the biomanufacturing process.
The Biomanufacturing Technology Roadmap is accelerating innovative manufacturing strategies for biopharmaceuticals.
Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict trends and areas for improvement.
Small-molecule therapeutics can also benefit from the implementation of PAT in the manufacturing process.
Regulatory Beat
New gene therapies and combination products require innovative regulatory approaches.
Perspectives on Outsourcing
In a productive year, 2017 was filled with acquisitions, facility expansions, and new biopharma technology.
Ask the Expert
SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
From the Editor
Developing and retaining qualified employees will test biopharma companies and CMOs alike.
lorem ipsum