BioPharm International-12-01-2017

December 01, 2017

New gene therapies and combination products require innovative regulatory approaches.

December 01, 2017

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

December 01, 2017

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

December 01, 2017

Biopharma employees reveal employment objectives, opportunities, and frustrations.

December 01, 2017

Single-use systems provide replaceable fluid paths.

December 01, 2017

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

December 01, 2017

A technology roadmap aims to drive and consolidate improvements in a process that has remained unchanged for more than 70 years.

December 01, 2017

A quality-by-design approach that implements PAT offers advantages in upstream cell-culture processing.

December 01, 2017

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.

December 01, 2017

The Biomanufacturing Technology Roadmap is accelerating innovative manufacturing strategies for biopharmaceuticals.

December 01, 2017

Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict trends and areas for improvement.

December 01, 2017

Small-molecule therapeutics can also benefit from the implementation of PAT in the manufacturing process.

December 01, 2017

Click the title above to open the BioPharm International December 2017 issue in an interactive PDF format.