BioPharm International-12-01-2017

New gene therapies and combination products require innovative regulatory approaches.

In a productive year, 2017 was filled with acquisitions, facility expansions, and new biopharma technology.

SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

Biopharma employees reveal employment objectives, opportunities, and frustrations.

Single-use systems provide replaceable fluid paths.

Developing and retaining qualified employees will test biopharma companies and CMOs alike.

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.

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