Product Guide. Biotherapy

Transcription

1 Product Guide Biotherapy

2 As a French company with an international dimension, Macopharma has become one of the leaders in the field of Transfusion medicine. Our products are used in more than 70 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 to the creativity of our R&D and Marketing teams, we have created a new «Biotherapy» division in order to speed up our development, to be more innovative while offering the best products and services to our customers in cell/tissue therapy, regenerative medicine and transplant. To our existing customers, we hope that this new 2014 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 de Lagrange-Chancel, CEO p 1

3 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 transplant. Thus, the Biotherapy range of products provides solutions for every step of the cellular therapy process from the collection, processing and expansion of stem cells, to the treatment and transplant of cells or organs to patients:. Cord Blood: Devices and bags for collection, processing, freezing and expansion of cord blood Hematopoietic stem cells.. Bio Banking: Medical devices for for cell & tissue transport and storage at very low temperatures.. Cell culture: Innovative closed systems and media for expansion & preservation of stem cells in GMP conditions for clinical application.. Photopheresis: Flexible process to efficiently treat patients with the Macopharma ECP technique: THERAFLEX-ECP.. Transplant: Solution and medical devices to optimize organ retrieval, preservation and transplantation. * Macopharma products that are available in the USA are identified with an asterisk. p 2

4 TABLE OF CONTENTS > Welcome from the CEO...p 1 > Introduction on Biotherapy at Macopharma...p 2 >Cord Blood...p 4 Collection Processing Freezing Expansion/preservation >Bio Banking...p 18 Tissues Cells Equipments >Cell Culture...p 31 Mesenchymal stem cells Hematopoietic stem cells Pancreatic islets >Photopheresis...p 49 Theraflex-ECP >Transplant...p 51 >Transfer sets...p 54 p 3

5 CORD BLOOD Macopharma offers a complete range to save cord blood cells, with an efficient process to achieve an optimal collection volume and maximise cell recovery. Today, most Netcord accredited bank members use Macopharma s systems to collect cord blood. Macopharma remains a privileged partner for all your leading developments, from the collection to the expansion of Cord Blood. These products are designed to enter the operating theatre and provide the user with a high quality product with optimal performance. p 4

6 MACOPHARMA CORD BLOOD COLLECTION 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 5

7 MACOPHARMA S CORD BLOOD COLLECTION BAGS: STEAM STERILISATION, A UNIQUE FEATURE ON THE MARKET! Due to the increase of cord blood collection during caesarean deliveries, cord blood collection kits must be sterilised in order to enter operating theatres. Macopharma s collection bags undergo steam sterilisation, providing them with a unique feature on the collection kit market, responding to a large need from both public and private cord blood banks. The packaged cord blood collection bag undergoes steam sterilisation and is then overwrapped (2) in Class The overwrapped collection kit is then pasteurised, to ensure minimal contamination on the outside of the inner package (1). Quarantine, delivery in a non sterile environment For safety reasons, and to bring the best product quality to our customers, a visual system has been implemented to check sterilisation. A patch on the bag enables a quick and easy look at the sterilisation status of the bag. This patch changes colour when sterilisation has been performed. Before sterilisation, the patch is pink. After sterilisation, the patch is black. Non sterile Packagedin Class and pasteurised Sterile p 6

8 CORD BLOOD COLLECTION For vaginal births Cord blood collection bag - Ref. MSC1201DU 30 cm 30 cm 70 cm 50 cm Collection volume 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 Cord blood collection bag - Ref. MSC1202PU Collection volume 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 7

9 CORD BLOOD COLLECTION For vaginal births and caesarean section deliveries Cord blood collection bag - Ref. MSC1205DU 27 cm 5 cm Collection volume 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 Cord blood collection bag - Ref. MSC1206DU Collection volume 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 8

10 CORD BLOOD Collection Equipment For additional information, see our brochure DOCON - Ref. 9DCN000 State of the art intuitive Cord 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 p 9

11 CORD BLOOD Collection & Processing Top&Bottom technique Cord blood collection and T&B volume reduction bag - Ref. MQT2205PU 5 cm 120 cm 65 cm 50 cm Collection volume Anticoagulant solution Needle size Additional features Collection Shelf life 27 cm Up to 250 ml 21 ml CPD + 8 ml CPD (rinsing bag) 12 G Protection sachet 2 needles 1 year 35 cm p 10

12 CORD BLOOD Processing Top&Bottom technique T&B volume reduction bag - Ref. VRT0000XU Fill collection Connections Shelf life Up to 250 ml 1 spike 1 pigtail for sterile docking 5 years 30 cm 50 cm 35 cm 65 cm p 11

13 CORD BLOOD PROCESSING Top&Top technique Volume reduction bag - Ref. VDC1002XU Fill collection Connections Shelf life Up to 200 ml 1 spike 1 female luer 2 injection sites 5 years Volume reduction bag - Ref. VDC1001XU Fill collection Connections Shelf life Up to 200 ml 1 spike 1 female luer 1 male luer 5 years p 12

14 CORD BLOOD Processing Equipment For additional information, see our dedicated brochure Macopress Smart (MPS) Automatic Cord Blood separator According to the type of communication Ref. 9MPSBRLAN - 9MPSBRWIFI - 9MPSBR485 Reference Features Accessories 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) p 13

15 CORD BLOOD Processing Accessories Foam bags for centrifugation of cord blood bags - Ref. H97IMC systems 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 14

16 CORD BLOOD FREEZING 3D Mini and Overwrap EVA cell freezing and storage bag - Ref. GSR0501AU 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 for storage -196 C to +40 C Shelf life 5 years Coming soon EVA overwrap for cell freezing bag GSR0501AU - Ref. GSR0010AU 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 15

17 CORD BLOOD EXPANSION Hematopoietic stem cells Media HP01 in EVA bag and in bottle - 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 PRESERVATION HP02 in bottle Product available on demand p 16

18 Bio Banking 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 optimal storage of cells and tissues. Both bag and connection have been designed to match users needs. 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 17

19 Bio Banking: Tissues p 18

20 Bio Banking Tissue banking Processing and cryopreservation Pots for tissue collection, transport and freezing - Ref. CDR systems Product code Volume (ml) Diameter (mm) Internal / External Height Optical specifications Shelf life Internal External Internal External Internal External Internal External CDR1000AU / / Transparent Transparent CDR1005AU / Transparent CDR2005AU / Transparent 4 years CDR7000AU / / Transparent Transparent CDR8000AU / / Transparent White p 19

21 Bio Banking Tissue banking EVA freezing bag Freezing holder Coming soon EVA bags for tissue freezing - Ref. GSR systems Product code Width (mm) Length (mm) Connections Shelf life GSR7002AU ext= male luer - 1 spike 2 needleless access ports 5 years Product code Width (mm) Length (mm) Connections Shelf life GSR5020AU GSR7010AU int=140 ext=150 int=160 ext= years GSR7010AU could also be used as an overwrap for the GSR7002AU p 20

22 Bio banking Tissue banking Aluminium bags Large bone bags Coming soon Aluminium bags for tissue freezing - Ref. XSR systems Product code Length (mm) Width (mm) XSR1010ZU Additional specifications Shelf life XSR2010ZU interpolated sheets 5 years XSR3010ZU Products are double overwrapped in peelable sachets. p 21

23 Bio Banking Tissue banking 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 stored for at least 24 hours before use between 3 C and 5 C. 350 ml Flexible EVA bag protected by a polyethylene/ polyethylene terephthalate overwrap 12 months AMM PTA N : TA Produit Thérapeutique Annexe (PTA) Marketing Authorisation in France p 22

24 Bio Banking: Cells Connector Needleless access port (NAC) Outlet ports Overwrap Needleless access port (NAC) Male luer Spike EVA Freezing bag Label Labelling window p 23

25 Bio Banking CELL BANKING EVA freezing bags EVA cell freezing and storage bag - Ref. GSR systems Product code Recommended Freezing volume (ml) Nominal volume (ml) Total length* (mm) External width (mm) GSR1000AU GSR2001AU GSR5001AU GSR7000AU GSR7001AU GSR8000AU GSR8001AU Connections 1 spike 1 male luer 2 needleless access ports Shelf life 5 years Storage temperature: Down to -196 C *with the outlet ports Freezing cassettes coming soon p 24

26 Bio Banking CELL BANKING EVA Overwraps 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

27 BIO BANKING CELL BANKING Cord Blood Freezing EVA cell freezing and storage bags - Ref. GDR1000AK 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 26

28 bio banking ACCESSORIES For cell processing and manipulation Cardboard boxes - Ref. H01FCB systems Reference Dimensions Suitable for Included H01FCB01 H01FCB02 H01FCB03 Length: 280 mm Width: 155 mm Thickness: 25mm Length: 471 mm Width: 152 mm Thickness: 17 mm Length: 276 mm Width: 155 mm Thickness: 22mm GSR5001AU GSR7000AU GSR7001AU GSR7002AU - 2 compartments to contain 2 sampling cryotubes - 2 identification windows for the control of freezing bag labels GSR8000AU / GSR2001AU GSR5001AU - 2 compartments to contain 2 sampling cryotubes - 4 identification windows for the control of freezing bag labels Sampling coupler Ref. EPE1016AU Sampling coupler with needleless access Ref. EPE2000AU Connections spike - female luer - injection site Connections spike + needleless access port p 27

29 equipments SEALER Thermal impulse sealer for EVA or Aluminium bags for cell and tissue freezing Ref. 9HPL4500 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 Adapted table: 9HPL4501 p 28

30 EQUIPMENTS SEALER 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 sealing EVA tubes (without precut) 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 p 29 Superior high frequency generator with one hand sealer for EVA tubes (with precut) and an additional hand sealer for PVC tubes in option.

31 CELL CULTURE Bruno Delorme obtained his PhD in cellular and molecular biology in MacoPharma Biotherapy. Bruno Delorme, PhD. R&D Biotherapy Director. Bruno acquired a strong background in the field of stem cell biology and tissue regeneration. He completed a post-doctoral placement in the field of skeletal muscle differentiation and regeneration before joining the INSERM to work on human blood circulating endothelial progenitor cells and their potential application for ischemic pathologies; he then focused on the use of human bone marrow s mesenchymal stem cells for connective tissue disorders. 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, where he is managing the development of scientific research projects for innovative technologies, as well as the dissemination of scientific publications and communications and being in charge of academic partnerships. Macopharma s Biotherapy division 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 skin lymphomas. p 30

32 MESENCHYMAL STEM CELLS MC3 System: Macopharma Closed Cell Culture system Macopharma and Corning Life Sciences are working together to provide their customers with the MC3 system, a unique solution adapted to each step of adherent stem cell 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. Reduced handling time. Products equipped with needleless access ports. Adapted to each step of adherent cell culture. Single use products to ensure product quality and safety. Ready and easy to use. Adapted medium and buffer bags p 31

33 CELL CULTURE MESENCHYMAL STEM CELLS MC3 system: Seeding Seeding kit - Ref. BC Connections 1 MPC connector 2 needleless access ports 1 spike p 32

34 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 33 CORNING CellSTACK

35 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 34

36 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 35

37 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 36

38 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 37

39 CELL CULTURE MESENCHYMAL STEM CELLS MC3 system: Media MEM alpha medium in EVA bag Ref Volume Use with: Storage Temperature Shelf life BC ml CellSTACK one or two chambers BC BC ml 1 L CellSTACK five chambers connections 1 female luer / 1 male luer / 1 twist-off, 1 injection site 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 38

40 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 1 L 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 39

41 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 40

42 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 41 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

43 Cell culture MESENCHYMAL STEM CELLS Bone Marrow collection For collection and transfer in the operating theatre Bone marrow transfer / collection bag - Ref. MSE0100Q 35 cm Volume of collection Anticoagulant solution Connection Shelf life Up to 450 ml 50 ml ACD Female luer 1 year Bone marrow transfer / collection bag - Ref. VSE6002Q Fill collection Connection Shelf life 30 cm Up to 1000 ml Female luer 5 years p 42

44 Cell culture MESENCHYMAL STEM CELLS Bone Marrow collection For collection and transfer in the operating theatre Bone marrow container / collection bag - Ref. MSM0000XU Volume of collection Connections Shelf life Up to 40 ml 2 female luers 1 male luer 1 one-way permanent clamp 5 years p 43

45 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 44

46 CELL CULTURE CO-CULTURE BAG New generation of culture bag Co-Culture bag - Ref. BC Volume 2 compartments Top : 400 ml for medium Bottom : 20 ml for cells Discontinuous welding for exchanges. 3D Bag. GMP product. Closed system. User friendly p 45

47 CELL CULTURE COMING SOON IN 2014 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 Closed system with specific medical device Automated medium exchange Temperature control and oxygenation system Touch screen graphical user interface GMP medium for islet preservation p 46

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

49 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

50 PHOTOPHERESIS THERAFLEX-ECP Extracorporeal Photochemotherapy UVA illumination EVA bag - Ref. XUV8501Q Nominal volume Volume Connections Shelf Life 3 L 300 ml 1 spike 1 injection site 5 years inside the overwrap 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

51 TRANSPLANT The current worldwide need to improve graft performance after organ and tissue transplant is still unmet. In partnership with academic research teams in France, Macopharma has developed organ preservation solutions and medical devices designed to support transplant teams in obtaining better patients outcomes. Our preservation solutions contain innovative compounds that minimise graft injury during transportation, storage and preservation. Our ergonomic and sterile medical devices are designed and adapted to facilitate organ and tissue collection in operating theatres. p 50

52 TRANSPLANT Organ conservation solution SCOT 15 solution for abdominal multi-organs Description Extracellular-type solution Hypothermic infusion 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 between 3 C and 5 C for at least 24 hours before use AMM PTA N : TA Produit Thérapeutique Annexe (PTA) Marketing Authorisation in France SCOT 15 Multi-organ abdominal in bottle - Ref. BT Volume Usage Shelf life 1000 ml Solution to infuse, preserve and transport abdominal organs at low temperature 12 months SCOT 15 Multi-organ abdominal in EVA bag - Ref. BT Volume Usage Shelf life 1500 ml Solution to infuse, preserve and transport abdominal organs at low temperature 12 months p 51

53 TRANSPLANT Organ RETRIEVAL Exsanguination line / bag for multi-organ retrieval - Ref. BT Volume of use 15 L Filling by gravity Connections Cannula with 2.5 m tubing + 1 clamp p 52

54 transfert set * * On-demand production p 53

55 transfert set SAMPLING SET Sample collection (PVC) Reference Volume Language Shelf Life Packaging VSE0000A FR VSE0000Y VSE0000YK 40 ml FR EN 5 years 20 VSE0000YL PT Reference Volume Language Shelf life Packaging VSE0001Y 100 ml En 5 years 20 p 54

56 transfert set Simple Transfer Set 300 ml (PVC) Reference Volume Language Shelf life Packaging VSE2001L PT - ISBT 40 VSE2001XA FR 30 VSE2001XL Spike PT - ISBT 5 years 40 VSE2001XQ EN - FR 60 VSE2001XR IT - ISBT ml (PVC) Reference Composition Language Shelf life (year) Packaging p 55 VSE4001Q EN - FR 5 35 VSE4001XA FR 5 30 Spike VSE4001XB EN 5 35 VSE4001XP PL - ISBT 5 35 VSE4002XB Bung UNIVERSAL 5 35 VSE4101XR IT - ISBT 5 30 VSE6003QS ES 5 15 Spike VSE8000XL PT - ISBT 5 15 VSE8001XL PT - ISBT 5 35 VSE8001XQ Female Luer EN - FR - GER - DUT 5 30

57 transfert set Simple Transfer Set 1000 ml (PVC) Reference Volume Composition Language Shelf life Packaging VSE6001Q 1000 ml Spike EN-FR 5 35 VSE6041XA 1000 ml Luer FR 5 15 p 56

58 transfert set Pooling Bag 600 ml (PVC) Reference composition Language Shelf life Packaging VSE3010XD 6 bungs EN 5 20 VSE4002XA 2 Spikes FR 5 30 VSE4011A 6 bungs FR 5 20 VSE4110XA 6 Spikes FR 5 15 VSE8003XQ 8 Spikes EN - FR - GER - DUT 5 15 VSE8004XB 6 bungs EN 5 20 VSE8004XQ 6 bungs EN - FR - ISBT ml and more (PVC) Reference Volume Composition Language Packaging Shelf life VSE6002XR Spikes IT - ISBT 30 5 VSE6002Z Spikes FR 25 5 VSE8001XB bungs EN - ISBT 25 5 VSE8014xa spikes FR 15 5 p 57

59 transfert set Distribution set Double set for distribution (PVC) Reference Volume Composition Language Packaging Shelf life VDE3011XA 400 Spike FR 25 VDE4003XA bungs FR ml and more (PVC) Reference Volume Composition Language Packaging Shelf life VRE4001XA 500 FR 20 Spike VRE7000XQ 500 FR 25 5 p 58

60 transfert set Distribution set Quadruple bags (PVC) Reference Volume Composition Language Packaging Shelf life VQE2001A 300 Spike FR 15 VQE2001XQ 300 Spike EN-FR 15 VQE6001XB 600 Bung EN 20 VQL0001XC 150 Bung FR 25 VQL0001XU 150 Bung UNIVERSAL + ISBT VQX0001XU 150 Spike FR VQX0002XU 150 Spike EN 15 VQX0003XU 100 Spike EN 20 4 Sextuple set (PVC) Reference Volume Composition Language Packaging Shelf life VXX2001XB 300 Spike EN 15 VXX6001XB 600 Bung EN 15 5 VXX6002XB 600 Bung EN 15 p 59

61 transfert set Phlebotomy set Collection volume : 600 ml (PVC) Reference Language Packaging Shelf life VSL7000PQ VSL7000YQ VSL7000YD VSL7001PQ VSL7001PD FR EN 20 5 p 60

62 transfert set TRANSFER CONNECTIONS AND SYSTEMS Reference Language Packaging Shelf life EPE1017A 9 S - 1 S EN 20 EPE1018A 12 S - 1 L FR 15 EFL0002XU 5 S - 1 S EN 30 5 Simple transfer set Reference Language Packaging Shelf life EPF0004C 1 N - 1S GER 125 EPF0005A 1 N - 1S FR 125 EPP0002A 1 S - 1 S FR 30 EFL0003XU 1 S - 1 S FR 300 EFL0006XD 1 S - 1 L EN 20 EFL0006XU 1 S - 1 L EN Pooling Systems Collection Line Tubings Reference Compostion Language Packaging Shelf life Reference Language Packaging Shelf life ESL0001GU 300 EN 5 EFL0001DU 500 EFL0000XC 20 m Tubing GER 10 2 EFL0000XD 20 m Tubing EN 10 5 EFL0000Y FR EFL0001XC 20 m Tubing GER 10 2 EFL0007XU 12 m Tubing EN 15 5 p 61

63 BIOTHERAPY Macopharma rue Lorthiois Mouvaux France Tel : + 33 (0) Maco Productions 200 Chaussée Fernand Forest Tourcoing France Tel : + 33 (0) Maco Productions Polonia Ul. Szwajcarska Wroclaw Polska Tel : MACO MD (Tunisia) Zone Industrielle de Chotrana 2056 Raoued, ARIANA TUNISIA Tel : Macopharma UK 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 88, avenue Royale B-7700 Mouscron Belgium Tel : + 32 (0) Macopharma Nordic AB Södra Strandvägen Helsingborg Sweden Tel : + 46 (0) Macopharma USA 3675 Crestwood Parkway, #260 Duluth, GA USA Tel : Maco spania Avenida de la Vega, 1 Edificio 3 - Planta Alcobendas, Madrid Spain Tel : Macopharma Italia Galleria Gandhi, 2/A Rho MI, Milan Italy Tel : Macopharma Australia PTY Level 9, Tower B 799 Pacific Highways, Chastwood Australia Tel : Macopharma Nederland B.V. Orteliuslaan BB Utrecht Nederland Tel : Macopharma Canada 1080 Beaver Hall, Suite GR-002 Montreal (QC) H2Z 1S8 Canada Tel : Macopharma Middle East JAFZA, Office LB15412, PO Box Dubaï United Arab emirates Tel : Macopharma transfusion solution Pvt Ltd DSM#006, DLF Commercial center Shivaji Marg, Moti Nagar, New Delhi, INDIA Tel : Macopharma russia Shumkina st.20-1, office Moscow RUSSIA Tel : Macopharma International GmbH Fribourg branch, Rue St-Pierre 18, CH-1701 Fribourg SWITZERLAND Tel : Macopharma Nordic P.O Box 3015 Elisenberg 0207 Oslo NORWAY Tel : Macopharma NEW ZEALAND BDO Auckland, Level 8, 120 Albert Street 1010 Auckland NEW ZEALAND [email protected] XB1GA01C - July 2014