Manufacturing

What ATMP developers should know when looking for a CMO

by Elena Meurer

As ATMP start-ups mature, they will face the following challenging decision: whether to develop, test, and manufacture its products in-house or to outsource the activities to a contract manufacturer (CMO). ATMP developers who do not have their own GMP facility or plans to set-up their own plant, will need to look for a CMO. In this article, Elena Meurer provides a comprehensive and structured guide how to select a CMO for the manufacture of ATMPs.

The Devil is in the Details – Trouble Shooting for Biopharmaceutical Products

by Karl Heller

Harmonious flow of the industrial processes greatly depend on systematically complying, updating and maintaining the SOPs. However, sometimes the worst happens and the product of the industrial manufacturing is not in compliance with the quality standards, which underscores the deviance from the SOPs. Karl Heller will tell you how such cases are handled and how trouble shootig is conducted in the processes of industrial scale.