The biopharmaceutical industry usually relies on traditional manufacturing practices to make and release products. This means release through reactive mechanisms in quality systems that can cause many problems, e.g., any deviations, mistakes, or problems must be investigated and closed after they have occurred. This can be up to several weeks after production and can cause significant delays in product release.
But is there a new way? One that will help organizations overcome difficulties in implementing the required technology, meet regulatory requirements, and build a clear business case to justify an investment?
The answer can be found in BioPhorum’s Operational vision: Adoption of in-line monitoring and real-time release.
A vision of the future
The paper gives an aspirational vision of biopharmaceutical manufacturing by showing a future that includes fully implemented in-line monitoring (ILM) and real-time release (RTR).
It includes full ILM, predictive analytics, and advanced process controls enabling the release of product in real time, with related predictive and preventative alerts, and the resolution of process, equipment, and other production issues.
But it does not stop there. The paper also gives a high-level strategic overview for engaging senior sponsors and stakeholders to achieve the vision of full ILM/RTR adoption with process analytical technology and embedded quality by design.
To help establish a baseline and set a target, the paper outlines a scaled approach to adoption – from stage 1 (all testing is offline and no testing in-line or at-line) to stage 5 (automatic process control and automatic release). Finally, the vision paints a picture of the ways of working needed to operate a factory with the technology of the future at stage 5.
Achieving the vision will improve efficiency and yield due to better process understanding, allowing real-time adjustment of conditions, and reducing the time to market. At the same time, RTR will reduce the time for existing products to get to patients and enable efficiencies in the supply chain.
The paper includes case studies from member companies demonstrating different approaches to and stages of ILM/RTR adoption. This is the first in a series of publications that will eventually form a playbook for ILM/RTR adoption covering all stages.
The wealth of data collected by ILM will give insights into manufacturing parameters and dependencies that were previously impossible to understand, leading to unprecedented control of variability and improvements in cost and speed of manufacturing.
Similarly, realizing the vision of true RTR would be transformative for industry, enabling the delivery of products to market significantly faster than is currently possible and opening up the potential for more life-enhancing products, including personalized medicines.
Making biopharmaceutical products is time-consuming and expensive, so faster and cheaper methods are always being sought. Implementing ILM/RTR will increase speed, potentially decrease costs, and be a quantum leap in the automation of the industry.