Attending Pharmig 2018, AstraZeneca's Karen Capper and GSK's Paul J Newby unveiled details of the Microbiology Modernisation Cross-industry Consortium (MMCC), an initiative that has been in the making since June 2018.
The MMCC is an evolving group currently formed by pharmaceutical giants:
- Astra Zeneca
Newby, however, explained the group is also reaching out to other key players in the pharma industry such as the cell and gene, and advanced therapy areas.
He commented: "We feel there is a mismatch between the academic experience of these emerging technologies and their position within the pharmaceutical cGMP area. Hopefully, by getting together, we can all share some good ideas."
The purpose of the MMCC is to catalyse transformational change in microbiology testing by establishing strategic partnerships. Newby pointed out this is particularly needed as the industry uses methods that "Louis Pasteur would recognise", he said.
The strategic partnerships are aimed to enable identification of new technologies and to develop best practices. It also calls for improved communication with authorities and regulators.
As a cross-industry body, the MMCC aims to become a united voice to the regulators in a move to stimulate acceptance of new validated technologies.
GSK's experience with the MMCC is towards two main drivers for modernisation:
- Real time or near real time microbiological analysis of product quality: this is the desired state but not possible with conventional growth-based methods.
- Microbiological test platforms with integrated data capture functionality: this is the desired state for environmental, process and product analysis.
Equally, AstraZeneca has identified various themes to further develop with MMCC, including:
- Increased process understanding, knowledge and robustness
- Ability to introduce the engineering technology available to us to improve patient protection and reduce waste due to batch rejection
- Reduction in cycle times
- Reduction in time to results
- Reduce in time to batch release or the ability to move stages of the production process on faster
- Faster supply chains
- Reduce data integrity issues
- Increase sustainability
Chaired by Alice Laures, Team leader, Future Analytical and Control Technologies at GSK, the MMCC aims to hold regular update meetings, expands its cross-company membership and industry network.
On the regulatory front, the MMCC expects to form a working group engaging with the MHRA Innovation Office, EMA and the FDA Emerging Technology Team.
Other areas of development include a sustainability initiative for endotoxin testing, container closure integrity (CCI), and to initiate a revision of Pharm Europa chapter 5.1.6.
Held in Nottingham on 28-29 November, Pharmig 2018 delivered world-class presentations on key issues relevant to microbiology. Read the event review in CT January 2019 issue.