Evaluation of the CompoMat G5 and CompoFlow and its potential for blood bank automation

Transcription

1 32nd International Congress of the ISBT Cancun,, Mexico, July Evaluation of the CompoMat G5 and CompoFlow and its potential for blood bank automation Professor Dr. Christian Seidl, MD Vice Medical Director Institute for Transfusion Medicine and Immunohematology German Red Cross Blood Transfusion Service Professor of Exp. Haematology Johann Wolfgang Goethe University Hospital Frankfurt/Main, Germany

2 Structure of Transfusion Services in Germany Blood transfusion services (BTS) German Red Cross (GRC), non-for-profit State / Community / University based, non-for-profit Private, for-profit holdings (share holders) Private, for-profit companies Hospital blood banks

3 The Three Columns of Blood Supply in Germany * : University BTS means: State/ Community based and University BTS Blood & Blood Product Supply University BTS* 15-2 % GRC BTS 75-8 % Private BTS <1%

4 German Red Cross Blood Transfusion Service Baden-Wuerttemberg Hessen, Nord und OST and affiliated institutions Provides services and products for more than 3 million (4%) of the German population... supplies 8 hospitals 15, mobile dates 1,25, whole blood donations 2, apheresis donations > 1,6, blood products > 5, volunteers 2, FTEs in 17 centers 7 University based transfusion services Berlin, Dresden, Frankfurt/Main, Heidelberg, Mannheim, Tübingen, Ulm/Donau Frankfurt oneu-ruppin ochemnitz ozwickau oplauen

5 ~ 1.25 Mio whole blood donations / y, 17 sites

6 Background Blood products in Germany are regulated based on the EU Blood directives (22/98/EC) andare classified as medicinal products (21/83/EC) Quality indicators must take into account that blood is a human product collected from individual donors (range in relevant parameters like hemoglobin (hb), platelet count, etc. Manufacturing of blood has to guarantee the best standardisation possible

7 Aim Evaluation of the CompoFlow System and Compomat G5 In the course of their general introduction in the German Red Cross Blood Transfusion Service Regulated Process multi-step & tiered measure transparency of plan and data discussion and agreement with the responsible staff in all institutes results shall be applied generally

8 Prerequisites (Regulated by Quality Management) (a) Initiation by Executive Directors - medical justification and need - commercial agreement / contract (b) Technical evaluation procedure -QM format (c) Medical evaluation - field study - regulated introduction

9 Steps Description of the Qualification Process Risk Analysis Discussion with Personnel on the operational level Phase : Compomat G5 Qualification 3-Phase (Steps) Qualification Process Risks: (1) Product quality not adequate RCC, PC, FFP (2) Performance not OK (3) no general benefit

10 DQ-regulated Introduction of the CompoFlow System and the Compomat G5 at the German Red Cross Blood Transfusion Service Step 1: Analyse Complete Unit 1% Buffy Coat RCC FFP PC HCT Hb Volume HCT, Hb Volume Hemolysis Residual cells Volume Factor VIII Residual cells Hemolysis PLT count, volume, residual cells, ph, CD62P Step 2: 1% HCT Hb Volume HCT, Hb Volume Hemolysis Residual cells Volume Factor VIII Residual cells Hemolysis Volume PLT count ph Step 3: 2% HCT Hb Volume HCT, Hb Volume Hemolysis Residual cells Volume Factor VIII Residual cells Hemolysis Volume PLT count ph

11 DQ-regulated Introduction of the CompoFlow System and the Compomat G5 at the German Red Cross Blood Transfusion Service Goal Units per day Units total Analysis complete sample product release Step 1: Sufficient Quality Robustness PC ~ 5 2 1% - Step 2: Stability of quality 1-2 ~ 2 1% 9% Step 3: Quality Robustness all components 1-2 ~ % 95-98%

12 DQ-regulated Introduction of the CompoFlow System and the Compomat G5 at the German Red Cross Blood Transfusion Service Further Aspects Amount of plasma recovered Volume G5 / G4: standard valve system blood bags vs. CompoFlow System Preparation with and without pool platelet production Location specifics (technical requirements, ) Training requirements Experience of personnel for manufacturing Preparation time Machine times Cost benefit analysis

13 Results Red Cell Concentrate (RCC) Volume [ml] Study Number Mean SD Min Max CV , , ,62 G5-II , ,2 RCC Volume [ml] I

14 Results Red Cell Concentrate (RCC) HCT [%] Study Number Mean SD Min Max CV G5-II ,24 52,7 64,8 3,8 RCC Volume [ml] RCC HCT [%] I I

15 Results Red Cell Concentrate (RCC) Hb [g/unit] * Study Number Mean SD Min Max CV G5-II ,1 5,98 44,1 71, 1,9 RCC Volume [ml] RCC HCT [%] RCC Hb [g/unit] I I I

16 Results Red Cell Concentrate (RCC) WBC [x 1E6/Unit] * Study Number Mean SD Min Max CV [%] G5-II RCC Volume [ml] RCC HCT [%] RCC Hb [g/unit] RCC WBC [x 1E6/Unit] , ,5 I I I I

17 Results Red Cell Concentrate (RCC) Hemolysis [%] * Study Number Mean SD I ,1 RCC Volume [ml] RCC HCT [%] RCC Hb [g/unit] RCC WBC [x 1E6/Unit] RCC RCC Hemolysis ,5 2 1, ,5,5 I I I I I

18 Results Red Cell Concentrate (RCC) Hemolysis [%] * RCC RCC Hemolysis Study Number Mean SD , ,5 I ,1 Hemolysis >.8 [n/%] Out of Specification (OoS) * I Statistical Process Control (1%) of RCC Number* OoS-N/% Mean min - max / G * 1% of RCC (12 month period)

19 Results Plasma (FFP) Volume [ml] Study Number Mean SD Min Max ,52 I Plasma: Volume [ml] I

20 Results Plasma (FFP) Factor VIII * Study Number Mean SD Min Max G5-II ,78 82,8 123 Plasma: Volume [ml] Plasma: Factor VIII I I

21 Results Plasma (FFP) Residual Leukocytes [x1e9/unit] Study Number Mean SD Min Max CV , ,2,13 88,8 I ,1,68 79,8 Plasma: Volume [ml] I Plasma: Factor VIII I,6,4,2 Plasma: Residual Leukocytes [x1e9/unit] I

22 Results Plasma (FFP) Residual Red Cells [x1e9/unit] * Study Number Mean SD Min Max CV 34,54,29,12 1,77 24,38,19,12,74 53,75 I 88,38,19,12,74 Plasma: Volume [ml] Plasma: Factor VIII ,6,4,2 Plasma: Residual Leukocytes [x1e9/unit] Plasma: Red Cells [x1e9/unit] 2 1 I I I I

23 Results Plasma (FFP) Residual Platelets [x1e9/unit] * Study Number Mean SD Min Max 34 7,67 3,22 21,9 CV 24 4,28 2,71 9,97 82,18 G5-II 88 6,11 2,74 15,1 41,98 Plasma: Volume [ml] Plasma: Factor VIII ,6,4,2 Plasma: Residual Leukocytes [x1e9/unit] 2 1 Plasma: Red Cells [x1e9/unit] Plasma: Residual Platelets [x1e9/unit] I I I I I

24 Results Platelet Concentrate (PC) Volume [ml] Study Number Mean SD Min Max CV , , ,4 3, I , ,48 PC Volumen [ml] I

25 Results Platelet Concentrate (PC) PLT [x 1E6/ml] Study Number Mean SD Min Max CV , I , ,15 PC Volumen [ml] PC PLT[x1E6/ml] I I

26 Results Platelet Concentrate (PC) WBC [x1e6/unit] * Study Number Mean SD Min Max CV ,1 I ,11,97 156,73 PC Volumen [ml] PC PLT[x1E6/ml] PC WBC [x1e6/unit] I I I

27 Results Platelet Concentrate (PC) RBC [x1e9/unit] Study Number Mean SD Min Max CV ,7 I 9,73, ,6 142,78 PC Volumen [ml] PC PLT[x1E6/ml] PC WBC [x1e6/unit] PC RBC [x1e9/unit] ,5 2 1,5 1,5 I I I I

28 Results Platelet Concentrate (PC) ph (PCPH) Study Number Mean SD Min Max I , PC PH 8 7,5 7 6,5 6 I

29 Results Processing Times Difference between Compomat G5 und G4 Study Number Mean SD Min Max G Difference in Minutes G4 vs. G5 min *

30 Conclusions I G5 PhasesI and IIrevealed: Efficient installation qualification of G5 RCC: yield (ca. 1g Hb / unit) quality(reduced hemolysis (Oos), residual leukocytes) ( CV: Volume, HCT, Hb) Plasma: quality(fviii increased, reduced Red Cells, PLT) PC: quality( CV in PLT content, residual leukocytes) processing me Steps ahead: meeting of production managers phase III running (product quality, robustness of process) calculate economical benefits

31 Conclusions I Processing (Time) Efficacy 5 Processing facilities 3 Processing facilities (consolidated) Processing facility - consolidated 18 x G5 (instead of 24 x G4) 25% higher production efficacy Capacity of 275. whole blood component separations / annually

32 Conclusions II In two field studies (phase I and phase II), the Compomat G5 in a standard default mode showed performance parameters comparable to the Compomat G4 after several years of fine-tuning Both, Compomat G5 and CompoFlow show very promising results regarding the product quality specifications required for pharmaceutical drugs Cost-benefit and robustness of process to analyse the currently running phase III

33 32nd International Congress of the ISBT Cancun,, Mexico, July Thank you very much for your attention! Muchas gracias por su atención! Institute for Transfusion Medicine, Frankfurt and Division of Production, Baden-Baden/Dresden Johannes Leibacher Burcu Erterek Hans-Ulrich Pfeiffer Ekkehard Richter Walid Sireis Torsten Tonn Erhard Seifried Fresenius Kabi Wolfgang Boecker Stefan Kolb Armin Reidel Helmut Bechtel Bernd Hanakam