Less than 1 min 22/06/22
Author name: met_ra_ric

Transitioning from Clinical to Commercial Manufacturing — Part 1: Pre-Product Registration Perspective

Successful process performance qualification (PPQ) and commercial launch requires planning well before manufacturing registration batches. This webinar is the first of a 2-part series. The series will focus on the recommended studies from a technical transfer group perspective that should be conducted pre-product registration and post-registration to ensure a reproducible and scalable manufacturing process during PPQ and commercial launch.

This first part of the webinar series will focus on studies for pre-registration activities. Registration manufacturing is critical to a product’s regulatory filing, creating the proposed process for commercial manufacturing. While some changes can be made to the process post-registration, the level of change and subsequent studies (both engineering and clinical) can be costly and severely impact the timeline to launch a product. Through the use of risk-mitigation techniques and understanding regulatory requirements upfront, critical studies can be identified prior to registration manufacture that will de-risk the scale-up process.

Do you have questions about process performance qualification or tech transfer in general? Are you wondering what steps you need to take to ensure successful registration manufacture and commercial launch?

Watch this webinar on-demand now