Question from: Silke Binninger Silke.Binninger@miltenyi.com at 2024-10-08 13:25:16

Cell and Gene Therapy

1. Chain of Identity / Chain of Custody

a) What kind of quality system is it?
Is it another one beside GMP and GCP? Because it is not really related to one of both systems…
b) Can ISBT128 be seen as standard in the US? What is the standard in Europe?
c) Which identifiers should be used for chain of identity of autologous CART cell products from cell collection all the way through CAR T cell administration?
• In addition to a unique patient should the second strong identifier be a donation related identifier (e.g. SEC/DIS) – but then: When does the chain start because this is only available after apheresis?
• ISBT128 introduces the CoI ID now – a company related, not trial specific unique identifier – this is a third permanent identifier in the chain. ISBT128 has certain rules for the definition – is it also used by organizations not following the ISBT128 standard? Is there an ISBT128-independent rule to create this number?
• Does anybody has experience with trial conduct in Japan? Which identifier can be used – we cannot get information about possible donation identifier?
d) How to build up a CoI and CoC in a case of non-autologous donations: a certain donor has to give the graft for preparation on IMP for a specific receiver? Is there already any recommendation? It is not just one chain of identifier because 2 different persons are concerned – and the correct connection of both persons needs to be ensured. Are there recommendations for the label on the LP (Donor) and on the label of the IMP (Donor to Recipient)?
e) Is it acceptable in an hospital internal clinical trial (CMO and Clinical site in the same hospital – no further sites involved), that patients real data are used to ensure the CoI – but are not used for any trial related documentation (even though the sponsor of the trial is an external company)?

2. Decentralised Manufacturing Process for ATMP

Responsibilities definition between Sponsor / “Centralised Monitoring Site” / Satellites
– as far as I learnt clear guidelines for this approach are under preparation. Is there already some kind of recommendation for this?
– Each patient has a separate production, production will take place in separate locations. In order to archieve comparability some kind of regular monitoring should be required – done by monitors trained in GCP and GMP (including knowledge about the production process). Is this already under consideration – are there any recommendations?

4. Temperature Monitoring

For the shipment of IMP for ATMP at 2-8°C – what kind of temperature monitoring is state of the art currently? Just loggers inside the cooling boxes to be read out during arrival? Loggers outside with a sensor inside? GPS control? We would be interested to see the available options – with whom should we connect?

5. Labelling of Apheresis Product

Which methods are recommended to receive a quality of the label of the apheresis product which allows the sponsor to receive all required information will not interfere too much to the standard methods of the apheresis sites (which are different in each site) and allow the apheresis sites to work as much as possible according to their SOPs and with their computer systems? With whom can we discuss available options?