Euro Commission Issues New Guideline for Quality Documentation Needed to Support Biologic Investigational Clinical Trials
Addressing quality requirements of an investigational medicinal product for a given clinical trial without sharing…
Dr. James Blackwell: It will not be business as usual. Sloppy industry quality and business practices of the past won’t be acceptable. Products need to be right first time and on time. So, in order to accommodate this manufacturing facilities should be designed for purpose which means they should be flexible, scalable, efficient, use closed processing systems wherever possible, and you really need to look for integrating your data and information technologies to assure that we have chain of custody and appliance to our quality standards throughout the supply chain from patient to patient. So, location and size need to account for the supply chain and timely patient delivery. This is often where you need to have conversations with your commercial team as well to understand the demand, the number of patients that are going to be serviced. So, depending on your business model and patient needs, that can significantly impact the size and location of these facilities. I think the definition of batch processing and batch area clearance will need to change for economic reasons and I think the regulatory authorities recognize this. You won’t be able to do a single patient in a suite and then do a batch era clearance <of the entire suite> to bring the next patient sample in. For most of these therapies the economics simply won’t allow that.
I think for a good model it’s Biogen’s Luterbach facility even though that’s very large scale in monoclonal antibody. I’ve seen three presentations on that project and in terms of how they’ve integrated data and they’re taking a view towards reducing costs as much as possible that is a model for how this industry will have to approach their production and patient needs. So, system and technologies exist to help even smaller companies start down this road. I encourage companies to start with paper records, make those paper records as simple as possible but with the end in mind in that at some point they will need to transition those to electronic batch records. But being able to integrate all these systems so that you release a batch based on the fact that you know what your deviations are early, and release based on exception. This will allow timely patient delivery.
Dr. James Blackwell, Ph.D. M.B.A. is the Founder and Principal Consultant of The Windshire Group. The Windshire Group offers “Comprehensive CMC and Management Consulting”sm to the regulated life science industry. For further information, please contact email@example.com; (+1) 844.686.5750
Please also join me at ISCT’s annual meeting May 2-5, 2018! I will be speaking May 5th during Quality and Operations Track Session 5 – Data Integrity – Requirements, Opportunities, Management, Reconciliation: The Future of Data Integrity for Cellular Therapies- Why You Need to Think About It Now… http://isct2018.com/program/