2021 Automation SIG

2021 Working Groups

As part of the SIG’s new format, we are switching up our usual one meeting a year and are swapping it for 5 continuous working groups, meeting (virtually) four times a year, but with on-going communication. We have partnered with the SCB to curate groups with topics which we know are currently leading debates and questions within the Automation community and regulatory bodies.

We kicked off the SIG in June 2021 with our first meeting, but there's still time for you to get involved, whether it's by joining one of the working groups, or by attending the feedback loop that takes place after each meeting in a virtual space. 


Our working groups for this year are: 

WORKING GROUP 1: Manufacturing Digitisation in Advanced Therapies

Topics covered:
 IT infrastructure at various stages of development, centralising data capture and analysis, interfacing with other machines, when is it a good idea to digitise considering barriers to entry, what is the best place to start, Industry 4.0 adoption, centralised approach for sharing data. 

Outcome: A report outlining hierarchy of need for digitising manufacturing as clinical programs scale up. The goal is to provide guidance to early to mid-stage biotechs on what they need to prioritise to be able to think about digitisation in later stages.

WORKING GROUP 2: Vein-toVein Tracking & Supply Chain Digitisation

Topics covered: Creating a single environment for supply chain data, connecting data coming from existing solutions, standardising collection centre data, supply chain data and manufacturing data, what will it take to get a vein-to-vein view and use that insight in logistics - from scheduling patients to tracking progress in manufacturing

Outcome: Create a whitepaper outlining gaps in processes, technology and standards on the journey to vein-to-vein tracking. Provide recommendations to the industry on areas of collaboration and to therapeutic biotechs on priorities in terms of setting themselves up for success

WORKING GROUP 3: Automating Release for Autologous Products

Topics covered:
In absence of tailored solutions for automating QC and release, what are we doing with the technology that we've got? How can I use automation to limit variabilily? Looking at common assays across advanced therapies and what opportunities does automation hold for those? Fill and finish automation. The long-term direction of travel is to eliminate QC facilities - what is on the wishlist of solutions to make this a reality? 

Outcome: Publish a collection of recommendations for industrialising QC for autologous products in today's environment. En route to the goal of industrialising production of autologous therapeutics, what practical solutions are being implemented today?

WORKING GROUP 4: Modularity & Flexibility in Closed Systems

Topics covered: What will it take to move away from single use? Standardisation or technology innovation? Closing the full system vs. closing individual unit operations - is the current technology landscape driven by lacdk of common design and standardisation or conflicting business models?

Outcome: A report divided into two parts - part 1 focusing on standardisation and part 2 focusing on technology innovation. Both looking to provide recommendations on gaps in current processes and potential ways forward.

WORKING GROUP 5: Aligning the Automation & Technology Roadmap to the Regulatory & Process Development Roadmap

Topics covered: Viewing a technology roadmap not as a technical challenge, but as a regulatory and process development challenge; product is not the process, thinking about automation in reverse - what is the long-term path, rather than how can I solve an immediate challenge

Outcome: A collection of recommendations on key strategies to employ when creating and rolling out an automation plan that will align with the regulatory and process development roadmap. Include a sample or template roadmap is possible

Each group will consist of 12-16 members, and will have a rapporteur and co-rapporteur who will jointly guide their respective members through the SIG process, not only defining and executing the outcomes, but also maintaining regular contact between meetings.
The meetings for the 2021/2022 Report will be held in June 2021, September 2021, December 2021 and March 2022. All meetings will be virtual.  
The Automation Community will be kept up to date on the proceedings of the SIG by regular blog posts outlining the key takeaways, along with a Report which will be published and shared in the latter months of 2022.