BioPharm International-01-01-2015

Regulatory Beat

January 01, 2015

The European Commission’s new structure has sparked controversy about its allocation of responsibilities and the impact on the development and approval of new medicines.

Protein Aggregation

January 01, 2015

Understanding and preventing protein aggregation is crucial to ensuring product quality and patient safety.

Manufacturing Best Practices

January 01, 2015

Switching grades of raw material late in the development cycle can be costly. Best practice says get it right at the beginning.

Outsourcing

January 01, 2015

There are significant differences between small molecules and biologics fill/finish capacity.

Regulatory Beat

January 01, 2015

Manufacturers are under pressure to develop pipelines, promote quality, and justify pricing.

Inside Standards

January 01, 2015

In late 2014, standards organizations continued to work towards harmonization and securing drug safety.

Process Validation

January 01, 2015

The author presents opportunities and challenges in implementing the product lifecycle approach.

Ligand-binding assays are fundamental to characterizing biosimilars.

From the Editor

January 01, 2015

New designations lead to faster drug approvals, but there is more work to be done.

2015 Biopharma Manufacturing Outlook

January 01, 2015

As more biologic drugs come to market, manufacturers will require improved bioprocessing technologies.

The authors review efforts to limit polymer degradation without significantly impeding cell growth.

Product Spotlight

January 01, 2015

Product Spotlight

January 01, 2015

Product Spotlight

January 01, 2015

Product Spotlight

January 01, 2015

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