TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 137 v2

To: Customers purchasing horse and sheep blood products

Products affected: See Appendix 1, below

It is our intention to change the Manufacturing Process of the products listed below. The details of the change and the reason for it are given below.

If you have any difficulties or concerns accepting the change, please contact us immediately.

Proposed Change Date: Phase in from 14-04-2025

Change Details:

Change to bag design on the above product codes, these products are supplied in 2,4,7 and 10L bags.

The change is required due to the incumbent supplier restricting availability on these bag lines.

We have taken the opportunity to develop the bag design to incorporate some customer design requests.

Reason for Change:

The incumbent supplier has restricted supply on one bag line and has indicated further restrictions will apply to the remainder of the product range, forcing TCS to find a long term supply option.

Considerations:

Extensive trials were held in house to ensure the bag quality, supply chain and end product quality were not affected by the proposed change. There is no significant difference in the connections available to the user, these have been kept consistent with the current supply.

Conclusion

The bags and their design have passed the TCS product trial criteria and incorporates customer design change requests. The change ensures long term stability of supply to both TCS and our customers.

V2 – Proposed change date updated to state ‘phase in’ as some stocks of bags from the incumbent supplier are still available for production use. New bags will be phased in from 14-04-2025 as stocks of existing bags become depleted.

Appendix 1

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Apr 2025