Phacilitate Leaders Forum

Tubing connectivity standards in advanced therapy bioprocessing

Tubing connectivity standards in advanced therapy bioprocessing

On 30th and 31st May 2018, Phacilitate held the SIG Automation event at The Grove Hotel, London. The event brought together around 120 senior individuals in the advanced therapy space, representing therapeutics developers, manufacturers, C(D)MOs, consultants, vendors, and other significant stakeholders. The event was held in a workshop-style format, designed to maximise the volume of discussion and generate insights through topic-lead, structured conversations. Outcomes of the event are to be formally published through a Rapporteurs Report, and a peer-reviewed journal submission.

Amongst all the issues raised, that of standardising fluid tubing formats for enhanced connectivity and de-risked manufacturing was arguably the most significant, having also been a major theme of the 2017 SIG Automation event. There are two major components of this: the physical characteristics such as size and connectivity, and the polymer chemistry. There was a clear call to arms both in the workshop-style discussion groups and in summarising remarks from the plenary speakers for an initiative designed to tackle this issue, and it was suggested by Stephen Ward (Cell & Gene Therapy Catapult) that a forum such as Phacilitate’s SIG Automation might be opportune.

Contribute to new standards at Phacilitate Leaders Europe

Phacilitate are committed to being more than an events company. We aim to contribute significantly and tangibly to the progression of the advanced therapy industry by bringing together our network to overcome all elements of risk undermining the successful delivery of high-quality advanced therapies to patients.

In response to the clear call for action voiced at Automation SIG, we are spearheading an initiative to form a working group committed to understanding the need, and developing proposed standards, for fluid tubing connectivity in advanced therapy bioprocessing. We are proposing that the working group hold their first meeting at Phacilitate Leaders Europe, taking place at the Royal Lancaster London, on September 11th-12th.

Where: Phacilitate Leaders Europe, Royal Lancaster London

When: 11 September

Time: 15:30 - 17:30 

Working group chair: Geoff Ball, Invetech

Confirmed participants from Anemocyte, Invetech, Cell and Gene Therapy Catapult, CellGenix , Adaptimmune, Fresenius Kabi, Terumo BCT, BPSA

The group will aim to technically assess the solutions currently available e.g. connectors, current tubing ID/OD, sterile connection device specifications at this meeting. 

The medium term goal is to develop a guidance document for the following properties (at a minimum and subject to change according to the decision of the working group):

  • Exterior tubing diameter
  • Lumen diameter
  • Polymer chemistry
  • Connection method

It is expected that the working group will wish to develop a different set of standards for equipment use in different environments. Specifically, tubing compatible with liquid nitrogen storage may desirably have different properties to those used in ambient temperatures.

Desired outcomes

The intention of developing standards in tubing connectivity are threefold:

  1. Minimise the cost, technical difficulty and validation workload associated with using devices from different vendors for neighbouring unit operations
  2. Minimise the cost, technical difficulty and workload associated with validating disposables and other materials used in manufacturing, by means of understanding, standardising and minimising the risk associated with leachables and extractables
  3. Encourage innovation in cell therapy bioprocessing by allowing new products and bioprocessing equipment to interface in a standard way with existing devices

Call to action

Phacilitate are currently undertaking a scoping exercise to understand the optimal route of progression for this initiative. We are interested in hearing from any stakeholder with an interest in the development of such standards, and who may or may not wish to participate in a working group at Phacilitate Leaders Europe.


 

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