BioPharm International-08-01-2015

Industry experts spoke to BioPharm International about the key considerations in the development of a drug-delivery device for a biologic drug, the importance of human factors engineering, the advantages of prefilled syringes, and the challenges in the manufacture of these devices.

Downstream Processing

August 01, 2015

Process maps and risk assessments are among the valuable tools operators can apply to reduce the risk of microbial contamination.

Upstream Processing

August 01, 2015

A thorough cell-bank testing plan is necessary to certify the safety and purity of a resulting biopharmaceutical product.

The authors explore the use of statistical experimental design and multivariate analysis to develop a drug substance formulation matrix.

Optimization of each phase in a chromatographic cycle has a positive impact on productivity.

Regulatory Beat

August 01, 2015

FDA and industry support global framework and collaborations to secure the supply chain.

Perspectives on Outsourcing

August 01, 2015

Biopharma companies are outsourcing more jobs to cut costs.

From the Editor

August 01, 2015

FDA notes progress in drug development, but cites scientific and funding roadblocks.

This article discusses cleaning validation of equipment dedicated to the production of a single API.

Industry experts discuss challenges, trends, and innovations in fluid handling.

Click the title above to open the BioPharm International August 2015 issue in an interactive PDF format.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to handle internal audit reports during inspections.