About this event:

Date: October 31, 2023

Time: 11 am EST | 8 am PST |

5 pm CET

Duration: 30 minutes

The design and build of a facility to support the clinical and commercial manufacturing of advanced therapies is fundamentally important to the success of those projects. In many cases, a retrofit of an existing mammalian therapeutic manufacturing facility may introduce an unreasonable amount of risk into the manufacturing processes for advanced therapies, which can end up delaying the commercialization of such therapies.

Constructing a new facility can often alleviate these concerns, provided that engineering and process controls are designed properly to support manufacturing in a CDMO environment, which often has special considerations including the ability to handle multiple cell lines, virus families, and client projects.

In addition to those specific design requirements, CDMO manufacturing also places a unique demand on the facility with respect to visitors, person in plant, and the monitoring of critical process steps.

In all cases, the introduction of quality risk management principles early in the design phase allows for best practice controls that can be implemented to ensure product quality, minimize contamination, and ensure success in bringing new therapies to market.

An effective initial design review and periodic change review from all stakeholders, including the quality assurance team, during the progress of the build can allow for a facility to be commissioned that is right the first time.