BioPharm International December 2017

December 2017 | Volume 30, Issue 12
BioPharm International December 2017
Cover Story
Biopharma employees reveal employment objectives, opportunities, and frustrations.
Features
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.
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