WORKING GROUPS

The Automation Working Groups are five distinct sessions hosted four times a year and designed to be a continuous discussion on the challenges, bottlenecks and solutions in advanced therapy manufacturing, technologies and supply chains. The groups meet virtually and communicate throughout the year.

In partnership with the SCB, Phacilitate curate the groups with topics that are currently leading debates and generating questions within the automation community and matters of contention with regulatory bodies.

Having kicked off the working groups in June 2021 with our first meeting, you can still get involved by joining one of the working groups, attending the feedback loop after each meeting, or joining our Phacilitate Members’ Network to observe and join the ongoing, year-round discussion.

Our working groups for this year are:

WORKING GROUP 1: 

Manufacturing Digitisation in Advanced Therapies

This session is hosted with the support of Global OT/IT Quality Systems and the Cell and Gene Therapy Catapult

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 for 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-to-Vein Tracking & Supply Chain Digitisation

This session is hosted with the support of AmerisourceBergen

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

This session is hosted with the support of Miltenyi Biotec

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

This session is hosted with the support of ScaleReadyTopics 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 lack 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

This session is hosted with the support of Sexton Biotechnologies and AmplifyBio

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