Protect the Process; Protect the Patient
Key learning objectives
|Understand the risks faced by production processes|
|Understand what process protection looks like|
|Learn what you can do to protect your process|
|Discover the pitfalls that could be avoided|
Once the time and energy has been expended to develop a production process for a molecule, you need that process to run in a way that is as repeatable and predictable as possible.
Picture a situation whereby a new blockbuster drug was not available due to a failure in the supply chain - the financial consequences and reputational damage are not difficult to imagine.
When you developed your process, you will have established your limits of operation, documented your critical quality attributes and no doubt employed some elements of quality by design. Hopefully you will have also built in some process protection, but what exactly is process protection? Well it can be many things to many people, for example:
• Contamination protection
• Protection against system failure
• Supply agreements
• Second sources of supply
During this webinar, we discuss how some of these elements come together to build a supply chain that ensures continuity in the provision of critical biopharmaceutical products to those that need them.