BioPharm International-11-01-2018

Recent equipment and updated product options offer improvement to a range of biopharmaceutical manufacturing tasks.

Survey results and record attendance may show positive signs for established and emerging biopharma regions.

Cover Story

November 01, 2018

Platform processes have improved monoclonal antibody scale-up. Can they do the same for personalized therapies?

Building up relevant expertise in-house will make writing spec sheets for software easier, according to Siegfried Schmitt, principal consultant at PAREXEL.

Features

November 01, 2018

Industry is searching for ways to deal with the criticality of ensuring data integrity.

Perspectives on Outsourcing

November 01, 2018

The growth in adoption of single-use systems for commercial manufacturing will be dramatic in coming years.

Application of multiple techniques at different conditions presents a more complete picture of a dynamic situation.

As biologic drugs grow increasingly complex, drug delivery mechanisms such as prefilled syringes are being adapted to meet the challenges.

This article will explore the requirements for media and supplements needed to maintain newer cell lines, such as those based on human cells and fungal cells.

The second half of this article describes the testing methods used by the authors to demonstrate the applicability of single-use mixing technology for virus inactivation.

Advanced therapy medicinal products pose unique manufacturing challenges that will require appropriate and thoughtful facility design and equipment.

Click the title above to open the BioPharm International November 2018 issue in an interactive PDF format.

To achieve a more dynamic marketplace, FDA is issuingguidance documents and targeted advisories to support R&D on complex generics and combination products.