BioPharm International-12-01-2017

New gene therapies and combination products require innovative regulatory approaches.

Perspectives on Outsourcing

December 01, 2017

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

Ask the Expert

December 01, 2017

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.

From the Editor

December 01, 2017

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

Features

December 01, 2017

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.

Features

December 01, 2017

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

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