Achieving Biologics Manufacturing Milestones Using A Systemic Approach To Technology Transfer

By Amit Jogi, Ph.D, Senior General Manager, Biopharmaceutical Operations, Syngene International Limited

A poor technology transfer has many ramifications – problems with initial batches, analytical testing, packaging, and potentially, patient safety. Conversely, a successful technology transfer ensures that product quality does not suffer, while also saving time and resources.

This Point of View explains how Syngene, a leading global CRO/CDMO, has devised a systemic approach to achieving ‘100% first time right’ technology transfer in Biologics manufacturing. The methodology comprises a risk-based approach for assessing incoming data from the client-side. This involves assessing confidence levels for processes and analytical methods using a Decision Tree, arriving at risk mitigation strategies, and finally executing the transfer using a detailed Technology Transfer approach document to achieve ‘100% first time right’.

The methodology has resulted in a track record of consistent yield, regardless of differences in infrastructure, equipment, raw materials, processes, and more, between the client’s site and Syngene.