Product Guide. Biotherapy

Transcription

1 Product Guide Biotherapy 2013

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3 Macopharma is a French company with an international dimension that has become one of the leaders in the field of Transfusion medicine. Our products are used in more than 55 countries. Within the last three decades, we have become one of the largest suppliers of blood bags and in-line systems for leucodepletion worldwide. We are now focusing on developing innovative concepts to support the processes involved in transfusion medicine, such as pathogen reduction technologies, prion removal and automation... Thanks to our customers and the creativity of our R&D and Marketing teams, we have formed a new division «Biotherapy» in order to accelerate our developments, be more innovative while offering the best products and services to our customers in cell/tissue therapy, regenerative medicine and transplantation. To our existing customers, we hope that this new 2013 catalogue will provide a useful overview of what Macopharma has to offer. To our new customers, we sincerely hope that you will enjoy reading this document and that you will find exciting products for your specific applications in Biotherapy. Ronald Delagrange Chancel, CEO p 1

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5 MACOPHARMA BIOTHERAPY As Transfusion medicine evolves towards new cell therapies, Macopharma has also started to diversify into biotherapies and has developed a wide range of products to assist its customers in the fields of cell & tissue therapy, regenerative medicine and transplantation. Thus the Biotherapy range of products provides solutions for every step of the cellular therapy process from collection, processing and expansion of stem cells, up to the treatment and transplantation of cells or organs to patients:. Collection: Cord blood and bone marrow collection and processing bags.. Cryopreservation: Medical devices for cell and tissue transport and storage at low temperatures.. Cell Culture: Innovative closed systems and media for the expansion of stem cells in GMP conditions for clinical applications.. Photopheresis: Flexible process to efficiently treat patients with the Macopharma ECP technique: THERAFLEX-ECP.. Transplant: Solutions and medical devices to optimize organ collection, preservation and transplantation. * Macopharma products available for USA are identified with an asterisk. p 2

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7 TABLE OF CONTENTS Welcome from the CEO...p 1 Introduction on Biotherapy at Macopharma...p 2 Needleless access Focus...p 4 Collection...p 5 Cord Blood...p 6 Equipment... p 17 Bone Marrow...p 20 Cryopreservation...p 22 Cell Storage...p 23 Tissue Storage...p 28 Equipment... p 32 Cell Culture...p 34 Mesenchymal stem cells...p 35 Hematopoietic stem cells...p 46 Pancreatic islets...p 47 Photopheresis...p 48 Theraflex-ECP...p 49 Transplant...p 50 Organ preservation...p 51 Coming soon in p 53 Contacts p 3

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9 NEEDLELESS ACCESS FOCUS With the aim of facilitating easy manipulation of the kits, MacoPharma offers a range of innovative features including a needleless connection providing valve safety port to replace female luers.. Compatible with all standardized luer-locks syringes or connectors and conforming to ISO standards.. Ease of connection is secured and facilitated thanks to the needleless access port.. On removal of the luer-lock tip of syringe, the self-sealing valve closes automatically allowing a closed system to be maintained and preventing any solution leakage or contamination during disconnection.. Multiple use with airtightness guaranteed (up to 200 connections/disconnections possible).. Any risk of disconnection during use is eliminated.. All aspects of the current use of the product remain unchanged. Needle-free port closed Needle-free port open p 4

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11 COLLECTION Macopharma offers a complete range to save cord blood cells, with an efficient process to to achieve an optimal collection volume and maximise cell recovery. At the present time, most Netcord accredited bank members are using Macopharma s systems to collect cord blood. Macopharma remains your privileged partner for your leading developments from collection to storage. Macopharma also has a specific c range of products for bone marrow collection. ction These products are designed ed to enter er the operating theatre and provide the user with a high quality product with optimal performance. p 5

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13 MACOPHARMA CORD BLOOD COLLECTION BAG Preventing needlestick injuries with a needle guard on each line One-way pemanent clamp to secure the collection unit at the end of collection Making sampling easier with an integrated injection site Ensuring optimal collection with a double-needle system (12-gauge needle) and back-eye needles* Increasing cell recovery with an in-line rinsing pouch * See focus next page p 6

14 Focus on back-eye needles Back-eye needles represent an attractive solution in order to increase the volume of umbilical cord blood collected, and to improve the blood flow during collection. In a context of continuous improvement of products and services, Macopharma proposes these needles on the cord blood collection devices. The back-eye needle shows many advantages: Faster blood flow from the vein to the cannula: lower % of collections subjected to coagulation or venous collapsing. Optimal cell recovery: the additional orifice at the back of the needle does not engender cell mortality. Strong positive effect on low volumes and on critic volumes: the median collected volume is almost 10% higher than with standard needles. with a volume higher than 70 ml is increased (by 16.67%). p 7

15 STERILITY OF MACOPHARMA CORD BLOOD COLLECTION BAGS: A UNIQUE FEATURE ON THE MARKET! Due to the increase of cord blood collections during caesarean deliveries, cord blood collection sets need to be sterile, to be displayed in the green zone of operation theatres. The steam sterilisation of the packaged cord blood bag brings to Macopharma Collection bags a unique feature of sterility of the collection set, responding to a large need from both public and private cord blood banks. The packaged cord blood collection bag is steam sterilised, then overwrapped (2) in Class The overwrapped collection set is then pasteurised, to ensure minimal contamination on the exterior of the inner package (1). Quarantine, delivery in a non sterile environment For safety reasons, and to bring the best product quality to our customer, a system of optical detection of the kit sterility was implemented. A patch stuck on the bag enables to have a quick and easy visual checking of the pack sterility. This patch changes colour when the sterilisation is performed. The patch is pink before the sterilisation When the pack is sterile, the patch is black A4 Non sterile Packagedin Class and pasteurised Sterile p 8

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17 COLLECTION CORD BLOOD COLLECTION for caesarean section deliveries and vaginal births Ref. MSC1205DU - Cord blood collection bag 27 cm 5 cm Volume of collection Anticoagulant solution Needle size Additional features Collection Shelf life 27 cm 120 cm Up to 200 ml 21 ml CPD + 8 ml CPD (rinsing bag) 12 G Suitable for caesarean section deliveries 2 needles 1 year Ref. MSC1206DU - Cord blood collection bag Volume of collection Anticoagulant solution Needle size Additional features Collection Shelf life 30 cm 120 cm Up to 200 ml 21 ml CPD + 8 ml CPD (rinsing bag) 12 G Suitable for caesarean section deliveries 1 needle 1 year p 9

18 COLLECTION CORD BLOOD COLLECTION for vaginal births Ref. MSC1201DU - Cord blood collection bag 30 cm 30 cm 70 cm 50 cm Volume of collection Anticoagulant solution Needle size Additional features Collection Shelf life Up to 200 ml 21 ml CPD + 8 ml CPD (rinsing bag) 12 G Protection sachet 2 needles 1 year Ref. MSC1202PU - Cord blood collection bag Volume of collection Anticoagulant solution Needle size Additional features Collection Shelf life 27 cm 5 cm 120 cm Up to 200 ml 21 ml CPD + 8 ml CPD (rinsing bag) 12 G Protection sachet Vacuvam for sampling 2 needles 1 year 27 cm p 10

19 COLLECTION CORD BLOOD PROCESSING T&B technique Ref. MQT2205PU - Cord blood collection and T&B volume reduction bag 5 cm 120 cm 65 cm 50 cm Volume of collection Anticoagulant solution Needle size Additional features Collection Shelf life 27 cm Up to 200 ml 21 ml CPD + 8 ml CPD (rinsing bag) 12 G Protection sachet 2 needles 1 year 35 cm Ref. VRT0000XU - T&B volume reduction bag 30 cm 50 cm Fill collection Connections Shelf life Up to 200 ml 1 spike 1 pigtail for sterile docking 5 years 35 cm 65 cm p 11

20 B B COLLECTION CORD BLOOD PROCESSING T&B technique Ref. MDT1200PU - Cord blood collection and T&B volume reduction bag Volume of collection Anticoagulant solution Needle size Additional features Collection Shelf life Up to 200 ml 21 ml CPD + 8 ml CPD (rinsing bag) 12 G Protection sachet 1 needle 1 year 30 cm 25 cm 45 cm 25 cm p 12

21 COLLECTION CORD BLOOD PROCESSING HES method Ref. VDC1002XU - Volume reduction bag Fill collection Connections Shelf life Up to 200 ml 1 spike 1 female luer 2 injection sites 5 years Ref. VDC1001XC - Volume reduction bag Fill collection Connections Shelf life Up to 200 ml 1 spike 1 female luer 1 male luer 5 years p 13

22 COLLECTION STORAGE OF cord blood Ref. GSR0501AU - EVA cell freezing and storage bag A B Product code GSR0501AU Freezing volume 25 ml A : 20 ml B : 5 ml Dimensions width (mm) length (mm) 57 mm +/- 2x86 mm +/- 3 Thickness 0.5 mm Connections 1 spike 1 male luer 2 needleless access ports Temperature range of storage -196 C to +40 C Shelf life 5 years Available during Q Ref. GSR0010AU - EVA overwrap for cell freezing bag GSR0501AU Product code Dimensions Thickness Suitable with cell freezing bag Shelf life GSR0010AU See drawing 0.35 mm GSR0501AU 5 years Storage temperature: Down to -196 C 89 p 14

23 COLLECTION STORAGE OF cord blood Ref. GDR1000AK - EVA cell freezing and storage bags Recommended Freezing volume (ml) Length (mm) Width (mm) Connections Shelf life 2x (10-30 ml) Storage temperature: Down to -196 C 3 female luers 1 injection site (latex free) 2 clamps 5 years p 15

24 COLLECTION STORAGE OF cord blood Ref. GSR systems - EVA cell freezing and storage bags Product code Recommended Freezing volume (ml) Nominal volume (ml) Length (mm) Width (mm) Connections Shelf life GSR1000AU spike GSR2001AU male luer 2 needleless GSR5001AU access ports 5 years Storage temperature: Down to -196 C p 16

25 COLLECTION EQUIPMENT for collection FOR ADDITIONAL INFORMATION, SEE OUR BROCHURE Ref. 9DCN000 - DOCON State of the art intuitive blood collection mixer Suitable for cord blood collection Dimensions Weight Options 205 x 460 x 215 mm (width x depth x height) 3.3 kg (without batteries) 9DCN200: Docon battery pack 9MSC : Macoscan QSI 9DCN420: Transport case With a specific program dedicated to Cord blood collection. p 17

26 COLLECTION EQUIPMENT for cord blood processing FOR ADDITIONAL INFORMATION, SEE OUR BROCHURE Macopress Smart (MPS) Automatic blood separator designed to fit your process With a specific program dedicated to Cord blood volume reduction. Ref. 9MPSBRLAN - 9MPSBRWIFI - 9MPSBR485 According to the type of communication Reference Features Accessories p 18 9MPSBRLAN 9MPSBRWIFI 9MPSBR485 4 integrated balances Lateral press Electronic motion DMS+ bi-directional communication Additional external balance: 9MPS040 Additional sealing handle: 9MPS050 Barcode reader Maco Scan QS i: 9MSC or 9MSC (with support) or 9MSC (Macoscan mobile+base)

27 COLLECTION ACCESSORIES for cord blood processing Ref. H97IMC systems - Foam bags for centrifugation of cord blood bags Product code Dimensions Material H97IMC01 H97IMC02 Length: 160 mm Width: 90 mm Thickness: 10 mm Length: 140 mm Width: 90 mm Thickness: 10 mm Standard PVC Standard PVC p 19

28 COLLECTION BONE MARROW COLLECTION for collection and transfer in the operating theatre Ref. MSM0000XU - Bone marrow container / collection bag Volume of collection Connections Shelf life Up to 40 ml 2 female luers 1 male luer 1 way-permanent clamp 5 years p 20

29 COLLECTION BONE MARROW COLLECTION for collection and transfer in the operating theatre Ref. MSE0100Q - Bone marrow transfer / collection bag 35 cm Volume of collection Anticoagulant solution Connection Shelf life Up to 450 ml 50 ml ACD Female luer 1 year Ref. VSE6002Q - Bone marrow transfer / collection bag Fill collection Connection Shelf life 30 cm Up to 1000 ml Female luer 5 years p 21

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31 CRYOPRESERVATION Over 20 years ago Macopharma developed EVA freezing bags suitable for cell cryopreservation at very low temperatures. Made of EVA (Ethyl Vinyl Acetate), these freezing bags are designed to tolerate long term storage at temperatures down to -196 C (the condensation point of nitrogen), facilitating the optimal storage of cells and tissues. Both the bags and the connections have been designed to match needs of the users. In addition to this, our range of products has been enlarged to encompass storage pots and aluminium bags for tissue collection, transportation and storage to provide users with a broad choice depending on their internal procedures. p 22

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33 CELL FREEZING AND STORAGE Needleless access port (NAC) Connector Outlet ports Spike EVA Freezing bag Male luer Needleless access port (NAC) Label Labelling window p 23

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35 CRYOPRESERVATION CELL STORAGE EVA freezing bags Ref. GSR0501AU - EVA cell freezing and storage bag A B Product code GSR0501AU Freezing volume 25 ml A : 20 ml B : 5 ml Dimensions width (mm) length (mm) 57 mm +/- 2x86 mm +/- 3 Thickness 0.5 mm Connections 1 spike 1 male luer 2 needleless access ports Temperature range of storage -196 C to +40 C Shelf life 5 years Available Q Ref. GSR0010AU - EVA overwrap for cell freezing bag GSR0501AU Product code Dimensions Thickness Suitable with cell freezing bag Shelf life GSR0010AU See drawing 0.35 mm GSR0501AU 5 years Storage temperature: Down to -196 C 89 p 24

36 CRYOPRESERVATION CELL STORAGE EVA freezing bags Ref. GSR systems - EVA cell freezing and storage bag Product code Recommended Freezing volume (ml) Nominal volume (ml) Length (mm) Width (mm) GSR1000AU Connections Shelf life GSR2001AU GSR5001AU GSR7001AU GSR8000AU GSR8001AU Storage temperature: Down to -196 C 1 spike 1 male luer 2 needleless access ports 5 years Ref. GSR systems - EVA overwraps for cell freezing bags Product code Width (mm) Length (mm) Suitable with cell freezing bag Shelf life GSR5020AU GSR7010AU int=140 ext=150 int=160 ext= GSR2001AU GSR5001AU GSR7001AU 318 GSR7001AU 5 years Storage temperature: Down to -196 C p 25

37 CRYOPRESERVATION CELL STORAGE EVA freezing bags Ref. GDR1000AK - EVA cell freezing and storage bag Recommended Freezing volume (ml) Length (mm) Width (mm) 2x (10-30 ml) Storage temperature: Down to -196 C Connections 3 female luers 1 injection site (latex free) 2 clamps Shelf life 5 years p 26

38 CRYOPRESERVATION ACCESSORIES for cell processing and manipulation Ref. H01FCB systems - Cardboard boxes Dimensions Length: 280 mm Width: 155 mm Thickness: 25 mm Dimensions H01FCB01 Included items 2 compartments to contain, 2 sampling cryo tubes, 2 identification windows for the control of freezing bag labels H01FCB02 Suitable with cell freezing bags Ref. Suitable with cell freezing bags Ref. GSR5001AU GSR7000AU GSR7001AU Length: 471 mm Width: 152 mm Thickness: 17 mm GSR8000AU Ref. EPE1016AU Sampling coupler Ref. EPE1016AU Sampling coupler with needleless access Connections spike - female luer - injection site Connections spike + needleless access port p 27

39 CRYOPRESERVATION TISSUE STORAGE for collection, transport and storage Ref. CDR systems - Pots for tissue collection, transport and freezing Product code Diameter (mm) Volume (ml) Height Optical specifications Shelf life Internal / External Internal External Internal External Internal External Internal External CDR1000AU / / Transparent Transparent CDR1005AU / Transparent CDR2005AU / Transparent 4 years CDR7000AU / / Transparent Transparent CDR8000AU / / White White p 28

40 CRYOPRESERVATION TISSUE STORAGE EVA freezing bag Ref. GSR systems - EVA bags for tissue freezing Product code Length (mm) Width (mm) Connections Shelf life GSR5020AU int=140 ext= GSR7010AU int=160 ext= years GSR7002AU int=150 ext= male luer - 1 spike 2 needleless access ports p 29

41 CRYOPRESERVATION TISSUE STORAGE Aluminium bags Ref. XSR systems - Aluminium bags for tissue freezing Product code Length (mm) Width (mm) Additional specifications Shelf life XSR1010ZU XSR2010ZU interpolated sheets 5 years XSR3010ZU p 30

42 CRYOPRESERVATION TISSUE PRESERVATION Solutions Vascular graft SCOT30 solution for storage (+4 C) and cryopreservation (-80 C or -150 C) Ref. BF Storage Volume Material Shelf life Temperature of preservation in its overwrap: between 2 C and 25 C. It must be placed during at least 24 hours at a temperature ranging between +3 C and +5 C before use. The solution can also be stored directly between 3 C and 5 C. 350 ml Flexible EVA bag protected by a polyethylene/ polyethylene terephthalate overwrap 12 months Produit Thérapeutique Annexe (PTA) Marketing Authorisation in France AMM PTA N : TA p 31

43 CRYOPRESERVATION EQUIPMENT for sealing Ref. 9MSL Macoseal TWIN EVA Mini 3D Superior high frequency sealer for EVA tubes and EVA cell freezing and storage bag Generator dimensions Generator weight Hand sealer Tubes diameter Option 232 mm x 91 mm x 91 mm (L x W x H) 2.1 kg Weight: 0.32 kg Dimensions: 200 mm x 28 mm (L x W) EVA Tube 1: 3.9 mm (inner) 5.4 mm (outer) / separation with decontaminated scissors EVA Tube 2: 2.95 mm (inner) 4.15 mm (outer) / separation with decontaminated scissors Reference 9MSL3630 Additional PVC hand sealer (PVC tube: from 2.5 to 5 mm, max 0.75 mm wall thickness) Possible to connect 2 hand sealers: The top port on the generator is dedicated to seal EVA tubes (without pre-cut) and Mini 3D bag with a specific EVA hand sealer. A second hand sealer for PVC tubes can be added. Ref. 9MSL Macoseal TWIN EVA Superior high frequency sealer for EVA tubes Generator dimensions Generator weight Hand sealer Tubes diameter Option 232 mm x 91 mm x 91 mm (L x W x H) 2.1 kg Weight: 0.32 kg Dimensions: 200 mm x 28 mm (L x W) EVA Tube 1: 3.9 mm (inner) 5.4 mm (outer) / separation with decontaminated scissors EVA Tube 2: 2.95 mm (inner) 4.15 mm (outer) PVC from 2.5 to 5 mm, max 0.75 mm wall thickness Additional PVC handle: 9MSL3630 Superior high frequency generator with one hand sealer for EVA tubes (with pre-cut) and an additional hand sealer for PVC tubes in option. p 32

44 CRYOPRESERVATION EQUIPMENT for sealing Ref. 9HPL Thermal impulse sealer for EVA or Aluminium bags for cell and tissue freezing Dimensions & weight Cutting length Seal width Sealing features Option: 9HPL (L) x 300 (W) x 220 (H) 18 kg 360 mm (integrated cutting device) 3 mm. Thermal impulse via 2 heated jaws. Seal triggering: Electrical foot (pad, electromagnetic closure) Bench-adaptable table in front of sealing jaws to maintain the Freezing EVA bags at the correct height during sealing 9HPL4501 p 33

45 CELL CULTURE Bruno Delorme obtained a PhD in 1997 in cellular and molecular biology. He acquired a strong background in the field of stem cell biology and tissue regeneration. He did a post-doctoral placement in the field of skeletal muscle differentiation and regeneration. He then joined the INSERM working on human blood circulating endothelial progenitor cells and their potential application for ischemic pathologies; he then focused on the use of human bone marrow mesenchymal stem cells for connective tissue disorders. MacoPharma Biotherapy. Bruno Delorme, PhD. R&D Biotherapy Director. He gained a strong experience in project coordination and published scientific papers on adult stem cell research in peer-reviewed journals. Today, Bruno Delorme is the R&D Biotherapy Director at Maco Productions SAS Laboratory, managing the development of scientific research projects for innovative technologies and is responsible for academic partnerships. He is also managing the dissemination of scientific publications and communications. The Biotherapy activity of Macopharma is specialised in cell therapy and tissue engineering. Working in collaboration with cell therapy centres, biobanks, research teams and hospitals we have developed a whole range of disposables and media for stem cell collection, processing and expansion. To cope with this challenge we developed a secure cell culture concept with clinical grade serum-free and xeno-free culture media dedicated to specific stem cell populations (such as hematopoietic and mesenchymal stem cells) and easy to manipulate closed systems. We also developed innovative solutions and medical devices for the preservation of cells, tissues and organs before transplantation. These products enhance safety, traceability and standardisation for stem cell research and clinical applications. We also provide technology for extracorporeal photochemotherapy (THERAFLEX-ECP), a cell therapy technique designed to induce a modulation of the immune response and especially for the treatment of the skin lymphomas. p 34

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47 MESENCHYMAL STEM CELLS MC3 System: Macopharma Closed Cell Culture system Macopharma and Corning Life Sciences are working together to provide their customers the MC3 system, a unique solution adapted to each step of adherent stem cells culture in closed system. Cell Seeding Medium Exchange Cell Harvesting. Large surface of culture with Corning CellSTACK (636 cm² to 3180 cm²). Closed system decreasing contamination risks. Reduces handling time. Products equipped with needleless need access ports p. Adapted to each step of ls culture of adherent cells. Single use products to ensure product quality and security.r Ready and easy to use. Adapted medium and buffer bags p 35

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49 CELL CULTURE MESENCHYMAL STEM CELLS MC3 system: Seeding Ref. BC Seeding kit Connections 1 MPC connector 2 needleless access ports 1 spike p 36

50 CELL CULTURE MESENCHYMAL STEM CELLS MC3 system: Seeding packages Seeding packages with CellSTACK Ref Included items Cell culture surface Seeding kit BC BC kit BC CORNING CellSTACK 1 chamber 1 MPC connector 636 cm 2 CORNING CellSTACK one chamber BC kit BC CORNING CellSTACK 1 chamber 2 MPC connectors 2 x 636 cm 2 CORNING CellSTACK one chamber MPC connector + BC BC kit BC CORNING CellSTACK 2 chambers 1 MPC connector 1 kit BC CORNING CellSTACK 5 chambers 1 MPC connector 1272 cm cm 2 CORNING CellSTACK two chambers CORNING CellSTACK five chambers p 37 CORNING CellSTACK

51 CELL CULTURE MESENCHYMAL STEM CELLS MC3 system: Medium exchange Medium exchange kits Ref Volume Use with: Connections BC BC ml 1000 ml CORNING CellSTACK 1 or 2 chambers 1 MPC connector 1 needleless CORNING CellSTACK 5 chambers access port 1 spike p 38

52 CELL CULTURE MESENCHYMAL STEM CELLS MC3 system: Medium exchange packages Medium exchange packages with MPC connectors Ref BC BC BC Included items 1 kit BC (500 ml) 1 MPC connector 1 kit BC (500 ml) 2 MPC connectors 1 kit BC (1000 ml) 1 MPC connector + p 39

53 CELL CULTURE MESENCHYMAL STEM CELLS MC3 system: Harvesting Harvesting kits Ref Volume Use with: Connections CORNING BC ml CellSTACK 1 or 2 chambers 1 MPC connector 3 needleless access ports BC ml CORNING CellSTACK 1 spike 5 chambers p 40

54 CELL CULTURE MESENCHYMAL STEM CELLS MC3 system: Harvesting packages Harvesting packages with MPC connectors Ref BC Use with: 1 kit BC (500 ml) 1 MPC connector BC kit BC (500 ml) 2 MPC connectors BC kit BC (1000 ml) 1 MPC connector + p 41

55 CELL CULTURE MESENCHYMAL STEM CELLS MC3 system: Media MEM alpha medium in EVA bag Ref Volume Use with: Storage Temperature Shelf life BC BC ml 675 ml CellSTACK one or two chambers CellSTACK five chambers GMP PRODUCT for clinical applications Between 2 C and 8 C 12 months Connections: 2 outlet ports DMEM medium in EVA bag Ref Volume Use with: BC ml CellSTACK one or two chambers GMP PRODUCT for clinical applications Storage Temperature Shelf life Between 2 C and 8 C 8 months p 42

56 CELL CULTURE MESENCHYMAL STEM CELLS MC3 system: Buffer Phosphate Buffered Saline solution (PBS) in EVA bag Ref Volume Use with: Connections Storage Temperature Shelf life BC BC ml 1000 ml CellSTACK one or two chambers CellSTACK five chambers GMP PRODUCT for clinical applications 2 outlet ports 1 female luer 1 injection site 1 male luer 1 twist off Between 2 C and 25 C 12 months p 43

57 CELL CULTURE MESENCHYMAL STEM CELLS MC3 system: Transfer bags Transfer EVA bags Ref Volume Connections Ref BC BC BC BC BC ml 350 ml 500 ml 1000 ml 2 twist off 1spike 1 needleless access port 1 injection site 1 male luer Ref BC Ref BC Ref BC p 44

58 CELL CULTURE MESENCHYMAL STEM CELLS Platelet lysate preparation kit Macopharma has developed in collaboration with a French blood centre a system dedicated to the preparation of platelet lysate in 3 steps. STEP 1 STEP 2 STEP 3 Freezing and Centrifugation Ref. GSR5050AU Filtration Ref. BC Distribution Ref. GNR1000AU p 45 Ref Volume Temperature of storage GSR5050AU 500 ml -80 C to +40 C Connections 1 spike 1 male luer 1 outlet 1 injection site 1 needleless access port Ref Volume Filtration Connections Shelf life BC ml Porosity of the filter: 0.65 μm Ref Bags Volume GNR1000AU 9 EVA bags 10 ml to 30 ml per bag Sterile connection 1 spike Temperature of storage -80 C to +40 C 1 year Shelf life 5 years Shelf life 2 years. Ready and easy to use. Closed system decreasing contamination risks. Adapted to GMP production. Cost effective technique

59 CELL CULTURE HEMATOPOIETIC STEM CELLS Media HP01 in bottle - Ref. BC Volume of medium Packaging Use Storage Temperature 500 ml PET bottle GMP PRODUCT for clinical applications Between 2 C and 8 C Shelf life 12 months HP01 in EVA bag - Ref. BC Volume of medium Use Storage Temperature Shelf life Connections 1000 ml GMP PRODUCT for clinical applications Between 2 C and 8 C 12 months 1 female luer 1 injection site 1 male luer 1 twist off p 46

60 CELL CULTURE PANCREATIC ISLETS Media PrisM in bottle Ref Volume of medium Packaging Use Storage Temperature Shelf life BC BC ml 1000 ml PET bottle GMP PRODUCT for clinical applications Between 2 C and 8 C 8 months PrisM in EVA bag Ref. BC Volume of Use medium 1500 ml GMP PRODUCT for clinical applications Storage Temperature Shelf life Between 2 C and 8 C 8 months p 47

61 PHOTOPHERESIS Extracorporeal Photochemotherapy (ECP) has been recognised by the scientific community as a therapeutic option to treat various disorders, such as:. Cutaneous T-cell lymphoma (Sezary syndrome). GVHD (acute and chronic). Organ transplant rejection. Autoimmune disorders Macopharma has developed a complete product range for the off-line treatment of ECP: THERAFLEX - ECP. Theraflex ECP Procedure Extracorporeal photochemotherapy (ECP) is based on the exposure of peripheral blood mononuclear cells to the photosensitizing agent (8-methoxypsoralen or 8-MOP) and UVA illumination. Mononuclear cells are harvested by cytapheresis and reinfused to the patient after cell illumination. UVA illumination + MNC collection + 8-MOP addition p 48

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63 PHOTOPHERESIS THERAFLEX-ECP Extracorporeal Photochemotherapy UVA illumination EVA bag - Ref. XUV8501Q Nominal volume Volume Connections 3 L 300 ml 1 spike 1 injection site 8-MOP solution - Ref. CSL1800XA Volume 5 ml Composition Chemical composition for 100 ml of solution: Methoxalen...2 mg Ethanol (96%) mg Glacial acetic acid mg Sodium acetate thrihydrate mg Sodium chloride...40 mg Water for injections ml Produit Thérapeutique Annexe (PTA) Marketing Authorisation in France AMM PTA N : TA Macogenic G2 UVA illumination device - Ref. 9MG2000 Dimensions 87 cm (width) x 64 cm (depth) x 37 cm (height) Included items and options Printers, scanner, LCD colour touch screen Weight 65 kg p 49

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65 TRANSPLANT MacoPharma aims to develop new technologies, medical devices and preservation solutions in order to support innovative developments in organ transplantation, to increase graft performance and to improve quality standards. The Transplant range of products is made of ready to use products (medical devices and solutions) dedicated to a use in surgery theatre during multi-organ harvesting. The goal is to optimise organ preservation, transport and to standardize the practices of organ harvesting. p 50

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67 TRANSPLANT ORGAN PRESERVATION Solutions Focus on SCOT 15 solution for abdominal multi organs Description Extracellular-type solution Hypothermic perfusion and preservation of organs Colloid: Polyethylene glycol (PEG) 20 kd at 15 g/l Storage Temperature of preservation in its overwrap: between 2 C and 25 C. It must be stored at temperatures ranging between +3 C and +5 C for at least 24 hours before use. The solution can also be stored directly between 3 C and 5 C Produit Thérapeutique Annexe (PTA) Marketing Authorisation in France AMM PTA N : TA SCOT 15 Multi organ abdominal in bottle - Ref. BT Volume Usage Shelf life 1000 ml Solution for preservation and storage at low temperature of abdominal organs 12 months SCOT 15 Multi organ abdominal in EVA bag - Ref. BT Volume Usage Shelf life 1500 ml Solution for preservation and storage at low temperature of abdominal organs 12 months p 51

68 TRANSPLANT ORGAN PRESERVATION Medical device NEW! Ref. BT Exsanguination line during multi-organ harvesting Volume of use 15 L Filling by gravity Connections Cannula with 2.5 m tubing + 1 clamp p 52

69 COMING SOON IN 2013 NEW! CELL CULTURE: PANCREATIC ISLETS PRISM SYSTEM PRISMd Device to work in a closed system and to improve pancreatic islet preservation PRISMa Automated system designed to control medium perfusion, medium exchange and islet harvesting PRISMm Defined and ready-to-use medium dedicated to islet preservation p 53

70 COMING SOON IN 2013 NEW! CO-CULTURE BAG NEW GENERATION OF CULTURE BAG. TILcells. 3D Bag. GMP product. Closed system. Easy to use p 54

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72 BIOTHERAPY Macopharma (Maco3) rue Lorthiois Mouvaux France Tel : + 33 (0) Maco Productions (Maco1) 200 Chaussée Fernand Forest Tourcoing France Tel : + 33 (0) Maco Productions (Maco5) 12 rue du Vertuquet Neuville-en-Ferrain France Tel : + 33 (0) Macopharma Polonia S.P.Z.O.O. Ul. Szwajcarska Wroclaw Tel : Maco Productions Tunisie rue El Houdaybya 2036 La Soukra Tel : Macopharma (UK) Ltd. 8th Floor - Regal House 70 London Road Twickenham - Middlesex TW1 3QS United Kingdom Tel : + 44 (0) Macopharma International GmbH Robert-Bosch-Strasse 11 D Langen Germany Tel : + 49 (0) Macopharma BeNelux sprl/bvba 88, avenue Royale B-7700 Mouscron/ Moeskroen Belgium Tel : + 32 (0) Macopharma Nordic AB Södra Strandgatan Helsingborg Sweden Tel : + 46 (0) Macopharma USA 3675 Crestwood Parkway, #260 Duluth, GA Tel : Macospania S.L Avenida de la Vega, 1 Oficina 16 Edificio 3 3ra planta Alcobendas Madrid - Spain Tel : Macopharma Italia S.T.L. Viale de Gasperi, RHO (MI) Tel : Macopharma Australia PTY LTD PO BOX 5547 West Chatswood NSW 1515 Australia Tel : Macopharma Nederland B.V. Orteliuslaan BB Utrecht Nederland Tel : Macopharma Canada Inc Beaver Hall, Suite GR-002 Montreal (QC) H2Z 1S8 Tel : [email protected] XB1GA01B - February 2013