Supporting Material

Interview

View our interview, Moving from Retrofitting to Made for Purpose Manufacturing Equipment, published December 2018, through Cell & Gene Therapy Insights.

In this interview, Nina Bauer, Head of Cell Therapy Commercial, and Richard Grant, Head of Acoustic Product Development, both with MilliporeSigma consider the following questions:

• With the recent run of cell and gene therapy approvals and an ever-increasing level of investment into this sector, what do you see as the biggest developments that have enabled this progress to date?
• What changes do you think are needed in order for this to grow into a scalable and sustainable industry?
• What do you see as potential pressure points in the supply chain that will need to be addressed as the industry scales?
• Cost of Goods continues to be a concern for cell and gene therapies – what are the key cost drivers and what steps can be taken to optimize them, thus potentially reducing the costs of these therapies?

Article

View our article, Novel equipment and process changes: implications for your manufacturing strategy (PDF Download).

In this article, we outline the main considerations from a broad GMP equipment compliance perspective, as well as indicating key resources and referencing guidelines for both Europe and the United States on how to navigate the regulatory aspects of manufacturing changes.

Webinar

View our webinar, Made-for-Purpose Manufacturing Solutions – The Key to Commercialization.

In this webinar, the team provides the latest data and developments on cutting edge novel bioprocessing tools. The team also discusses:

• Manufacturing cost drivers and key risk factors to commercial success
• Current State of Affairs in manufacturing technologies
• How can we achieve commercially viable routine in manufacturing?
• What is acoustophoresis and why is it important to cell processing?

Webinar

View our webinar, Let’s Talk Integration, published December 2019 through Cell & Gene Therapy Insights.

This webinar provides a short example of the ekko™ system processing cell aggregates while integrated with a bioreactor. A cross-functional panel discuss integration challenges and learnings related to an integration strategy.

• A comprehensive view of key considerations when implementing integrated solutions from the perspective of process development, automation and regulatory
• First-hand examples of implementing automation strategies and technologies

When, where and how to consider implementing such technologies and the balance of risk / benefit