Milano, October 2003. Dear Customer,. This is to inform you that Instrumentation
Laboratory (IL) will be making changes to the. Chromogenix Coatest Factor VIIII ...
Milano, October 2003 Dear Customer, This is to inform you that Instrumentation Laboratory (IL) will be making changes to the Chromogenix Coatest Factor VIIII (Art. No. 821033) and Coatest FVIII:C/4 (Art. No 821918) kits. This action will occur in 2 phases. In phase 1, the natural phospholipid currently used in the Coatest Factor VIII and FVIII:C/4 kits will be replaced with a synthetic phospholipid. This change in raw material will not have any impact on the performance of the kit, which means that you, as a Coatest FVIII and FVIII:C/4 user, will continue to get the same test results during your transition to the new kit format. We have taken great care to optimize the new kit to give performance consistent with that of the current product. This 2-phase cross-over was not anticipated. We at Chromogenix/IL fully understand the impact that this modification might have on your laboratory routine, however due to circumstances beyond our control, we are forced to make this change. We will soon deplete the sole source of natural porcine phospholipid currently used in Coatest FVIII and Coatest FVIII:C/4 kits. Only one lot of this raw material was ever produced by Chromogenix AB, Sweden, and until now all Coatest FVIII and Coatest FVIII:C/4 kits were produced using this single phospholipid lot. For the past year and a half, the R&D group at IL has made every effort to produce the original Chromogenix material, however our attempts have not been successful. Therefore, it was decided to incorporate the synthetic phosholipid into the Coatest FVIII and Coatest FVIII:C/4 kits. This decision was not made lightly. Chromogenix/IL believes that this course of action is in the best interest of the Coatest FVIII and FVIII:C/4 kits and users. Synthetic phospholipids have been used successfully in the Coamatic FVIII kit for many years, and will provide the Coatest FVIII and FVIII:C/4 kits with improved quality, consistency of performance, and manufacturability. We had hoped to be able to continue to provide you with the original Coatest FVIII and Coatest FVIII:C/4 kits during the transition, but due to these circumstances, the 2-phase plan was initiated. There will be a limited number of original, unmodified kits manufactured before the natural phospholipid is depleted. In Phase 2, there will also be changes to the substrate component and the buffer component in addition to the synthetic phospholipid. This will result in a new test kit with higher sensitivity and better compliance with the pharmacopoeial requirements. We value your business as a Chromogenix customer, and we appreciate your patience and support as we make this transition from natural to synthetic phospholipid for the Coatest FVIII and Coatest FVIII:C/4 kits. Best regards R&D, Marketing Chromogenix / Instrumentation Laboratory
In summary we will have two phases for changes, which are subdivided as follows:
Phase 1 Phospholipid substitution from porcine to synthetic material Kit Components Coatest FVIII Coatest FVIII:C/4
Change during 2004
S-2222 + I-2581 FIX + FX CaCl2 Buffer Phospholipid
No change No change No change No change Change from natural to synthetic material
• A first batch of the Coatest FVIII kit incorporating the synthetic phospholipid will be produced in January 2004. NOTE: Depletion of the inventory of Coatest FVIII and Coatest FVIII:C/4 with the current porcine phospholipid will occur approximately during the first half of 2004 (considering the current worldwide demand).
As stated, we are also developing a new formulation of Coatest FVIII and FVIII:C/4. The changes of the new formulation consists of:
Phase 2 Substrate change and increased BSA concentration
Current formulation S-2222 + I-2581, 10 mL FIX + FX CaCl2 Buffer 2% BSA (10 x), 20mL Phospholipid
New Formulation S-2765- I-2581, 12 mL No change No change 10% BSA (10 x), 20 mL Synthetic Phospholipid
• This new formulation will be introduced during year 2004 and it will completely substitute the current ones.
The Art. No. and Product Name will change as follows:
Current kit
New Formulation
821033 63: Coatest FVIII 821918 63: Coatest FVIII:C/4
824086 63: Coatest SP FVIII 824094 63: Coatest SP FVIII:C/4
