product guide biotherapy · product guide biotherapy 2014. macopharma is a french company with an...

Product GuideBiotherapy

2014

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 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 removaland automation...

Thanks to our customers and the creativity of our R&D andMarketing 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 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 Delagrange Chancel, CEO

Macopharma is a French company with an international dimension

p°1

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:

. Cord Blood: Devices and bags for collection, processing, freezing and expansion of cord blood Hematopoietic stem cells.

. Bio Banking Medical devices for cells & 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 collection, preservation and transplantation.* Macopharma products available for USA are identified with an asterisk.

p°2

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

1

p°4

Macopharma offers a complete range to save cord blood cells, with an efficient process 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 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.

CORD BLOOD

Macopharma offers a complete range to save cord blood cells, with an efficient process to achieve an optimal collection volume and

privileged partner for your leading developments from collection to

These products are designed to enter the operating theatre and provide the user with a high quality product with optimal

p°5

MACOPHARMACORD BLOOD COLLECTION

Preventing needlestick injuries with a needle guard on each line

Ensuring optimal collection with a double-needle system

(12-gauge needle)and back-eye needles*

* See focus next page

One-way pemanent clamp to secure the collection unit

at the end of collection

Making sampling easierwith an integrated

injection site

Increasing cell recovery with an in-linerinsing pouch

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 10 000. The overwrapped collection set is then pasteurised, to ensure minimal contamination on the exterior of the inner package (1).

The patch is pink before the sterilisation

When the pack is sterile, the patch

is black

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.

Quarantine, deliveryin a non sterileenvironment

1

2

3

2007-09A4

Non sterile

Packagedin Class 10 000 and pasteurised

Sterile

Non sterile

Packagedin Class 10 000 and pasteurised

Sterile

p°6

COLLECTIONFor vaginal births

CORD BLOOD

Cord blood collection bag - Ref. MSC1201DU

Cord blood collection bag - Ref. MSC1202PU

Volume of collection

Anticoagulant solution

Needle sizeAdditional features

Collection Shelf life

Up to200 mL

21 mL CPD +8 mL CPD

(rinsing bag)12 G

Protection sachet

2 needles 1 year





Up to200 mL

21 mL CPD +8 mL CPD

(rinsing bag)12 G

Protection sachet

Vacuvamfor sampling

2 needles 1 year

Specifications

Specifications

30 cm

30 cm

70 cm

27 cm

27 cm

5 cm

50 cm

120 cm

p°7

COLLECTIONFor vaginal births and caesarean section deliveries

CORD BLOOD



p°8





Up to200 mL

21 mL CPD +8 mL CPD

(rinsing bag)12 G

Suitable for caesarean

section deliveries

2 needles 1 year





Up to200 mL

21 mL CPD +8 mL CPD

(rinsing bag)12 G

Suitable for caesarean

section deliveries

1 needle 1 year

Specifications

Specifications

27 cm

30 cm 120 cm

27 cm

5 cm

120 cm

CORD BLOOD

DOCON - Ref. 9DCN000State of the art intuitive Cord Blood Collection mixerSuitable 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 pack9MSC10014596: Macoscan QSI

9DCN420: Transport case

Specifications

FOR ADDITIONAL INFORMATION,

SEE OUR BROCHURE

p°9

COLLECTIONEquipment

CORD BLOOD

COLLECTION & PROCESSINGTop&Bottom technique

Cord blood collection and T&B volume reduction bag - Ref. MQT2205PU





Up to250 mL

21 mL CPD +8 mL CPD

(rinsing bag)12 G

Protection sachet

2 needles 1 year

Specifications5 cm

120 cm

27 cm

65 cm

35 cm

50 cm

p°10

CORD BLOOD

PROCESSINGTop&Bottom technique

T&B volume reduction bag - Ref. VRT0000XU

Fill collection Connections Shelf life

Up to250 mL

1 spike1 pigtail for sterile docking

5 years

Specifications

30 cm

65 cm35 cm

50 cm

p°11

CORD BLOOD

PROCESSINGHES method

Volume reduction bag - Ref. VDC1002XU


Up to200 mL

1 spike1 female luer

2 injection sites5 years


Up to200 mL

1 spike1 female luer1 male luer

5 years

Specifications

Volume reduction bag - Ref. VDC1001XU

Specifications

p°12

CORD BLOOD

PROCESSINGEquipment

Macopress® Smart (MPS)Automatic Cord Blood separator

According to the type of communicationRef. 9MPSBRLAN - 9MPSBRWIFI - 9MPSBR485

Reference Features Accessories

9MPSBRLAN9MPSBRWIFI9MPSBR485

4 integrated balancesLateral press

Electronic motionDMS+ bi-directional communication

Additional external balance: 9MPS040 Additional sealing handle: 9MPS050

Barcode reader Maco Scan QS i: 9MSC10014596 or 9MSC10014621(with support)

or 9MSC10014493 (Macoscan mobile+base)

Specifications

FOR ADDITIONAL INFORMATION,

SEE OUR DEDICATED BROCHURE

p°13

CORD BLOOD

Specifications

Product code Dimensions Material

H97IMC01Length: 160 mmWidth: 90 mm

Thickness: 10 mmStandard PVC

H97IMC02Length: 140 mmWidth: 90 mm

Thickness: 10 mmStandard PVC

Foam bags for centrifugation of cord blood bags - Ref. H97IMC systems

PROCESSINGAccessories

p°14

FREEZING3D Mini and Overwrap

CORD BLOOD

EVA cell freezing and storage bag - Ref. GSR0501AU

Specifications

EVA overwrap for cell freezing bag GSR0501AU - Ref. GSR0010AU

Specifications

Product code

Dimensions ThicknessSuitable with cell

freezing bagShelf life

GSR0010AU See drawing 0.35 mm GSR0501AU 5 years

Product code

Freezing volume

Dimensions width (mm)length (mm)

Thickness ConnectionsTemperature

rangeof storage

Shelf life

GSR0501AU25 mL

A : 20 mLB : 5 mL

57 mm+/- 2x86 mm

+/- 30.5 mm

1 spike1 male luer2 needlelessaccess ports

-196°Cto +40°C

5 years

Storage temperature: Down to -196°C

A B

89

69

100

Coming soon

p°15

CORD BLOOD

EXPANSIONHematopoietic stem cells Media

HP02 in bottle

HP01 in EVA bag - Ref. BC0100030

SpecificationsVolume of medium

UseStorage

TemperatureShelf life Connections

1000 mL

GMPPRODUCTfor clinical

applications

Between2°C and 8°C

12 months

1 female luer1 injection site

1 male luer1 twist off

PRODUCT AVAILABLE ON DEMAND

p°16

PRESERVATION

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 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.

BIO BANKINGOver 20 years ago Macopharma developed

suitable for cell cryopreservation at very low temperatures.

Made of EVA (Ethyl Vinyl Acetate),

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

p°17

BIO BANKING:Tissues

p°18

BIO BANKING

TISSUE BANKINGProcessing and cryopreservation

Specifications

Product code

Volume (mL)Diameter (mm)

Internal / ExternalHeight Optical specifications Shelf life

Internal External Internal External Internal External Internal External

4 years

CDR1000AU 40 80 34.8/41.4 48.6/55.4 53.5 59.1 Transparent Transparent

CDR1005AU 40 34.8/41.4 53.5 Transparent

CDR2005AU 80 48.6/55.4 59.1 Transparent

CDR7000AU 250 500 72/80.2 86.5/95.2 81.5 105.3 Transparent Transparent

CDR8000AU 500 1000 86.5/95.2 108.7/118.2 105.3 123.8 Transparent White

Pots for tissue collection, transport and freezing - Ref. CDR systems

p°19

BIO BANKING

TISSUE BANKINGEVA freezing bag

EVA bags for tissue freezing - Ref. GSR systems

Specifications

Product code

Length (mm) Width (mm) Connections Shelf life

GSR5020AUint=140ext=150

318

5 years


318

Freezing holder coming soon

Specifications

Product code



2741 male luer - 1 spike

2 needleless access ports5 years

GSR7010AU could also be used as an overwrap for the GSR7002AU

p°20

BIO BANKING

Aluminium bags for tissue freezing - Ref. XSR systems

Specifications

Product code Length (mm) Width (mm)Additional

specificationsShelf life

XSR1010ZU 120 155

5 yearsXSR2010ZU 180 220 5 interpolated sheets

XSR3010ZU 210 305

TISSUE BANKINGAluminium bags

Big bones bagsComing soon

p°21

BIO BANKING

TISSUE BANKINGSolutions

Vascular graft SCOT30 solution for storage (+4°C) and cryopreservation (-80°C or -150°C) – Ref. BF0200060

Specifications

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 bagprotected by apolyethylene/polyethylene terephthalate

overwrap

12 months

AMM PTA N°: TA 07.05.69

Produit Thérapeutique Annexe (PTA) Marketing Authorisation in France

p°22

BIO BANKING:Cells

Needleless access port(NAC)

Spike

Male luer

Needleless access port(NAC)

Label

Labelling window

EVA Freezing bag

Outlet ports

Connector

p°23

BIO BANKING

CELL BANKINGEVA freezing bags

EVA cell freezing and storage bag - Ref. GSR systems

Specifications

Product codeRecommended

Freezing volume (mL)

Nominal volume (mL)


GSR1000AU 10-30 110 230 75

1 spike1 male luer2 needlelessaccess ports

5 years

GSR2001AU 30-70 215 180 130

GSR5001AU 60-100 400 225 130

GSR7000AU 100-180 820 274 150

GSR7001AU 80-150 570 256 130

GSR8000AU 140-280 1920 431 150

GSR8001AU 120-250 940 313 130


EVA cell freezing and storage bag - Ref. GSR systems

Snap freezing cassetteComing soon

p°24

BIO BANKING

CELL BANKINGEVA Overwraps

Ref. GSR systems - EVA overwraps for cell freezing bags

Specifications

Product code Width (mm) Length (mm) Suitable with cell freezing bag Shelf life


318GSR2001AUGSR5001AUGSR7001AU 5 years


318 GSR7001AU


p°25

BIO BANKING

Recommended Freezing volume (mL)

Length (mm)

Width (mm)

Connections Shelf life

2x (10-30 mL) 230 75

3 female luers1 injection site

(latex free)2 clamps

5 years

Specifications


CELL BANKINGCord Blood Freezing

EVA cell freezing and storage bags - Ref. GDR1000AK

p°26

BIO BANKING

ACCESSORIESFor cell processing and manipulation

Specifications

Specifications Specifications

H01FCB01

Dimensions Included itemsSuitable with cell freezing bags Ref.

Length: 280 mmWidth: 155 mm

Thickness: 25 mm

2 compartments to contain,2 sampling cryo tubes,

2 identificationwindows for the controlof freezing bag labels

GSR5001AUGSR7000AUGSR7001AU

Connections spike - female luer - injection site Connections spike + needleless access port

H01FCB02

DimensionsSuitable with cellfreezing bags Ref.


Thickness: 17 mmGSR8000AU

Cardboard boxes - Ref. H01FCB systems

Sampling couplerRef. EPE1016AU

Sampling coupler with needleless accessRef. EPE1016AU

p°27

H01FCB03

Dimensions IncludedSuitable with cellfreezing bags Ref.


Thickness: 22 mm

. 2 compartments to contain 2 SCT

. 4 identifications windows for the controlof freezing bag labels

GSR2001AUGSR5001AU

EQUIPMENTS

SEALER

Specifications

Dimensions& weight

Cutting lengthSealwidth

Sealing featuresOption:

9HPL4501

520 (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 tablein front of sealing jaws to

maintain the FreezingEVA bags at the correct

height during sealing

Thermal impulse sealer for EVA or Aluminium bags for cell and tissue freezing Ref. 9HPL4500

Adapted table: 9HPL4501

p°28

EQUIPMENTS

Specifications

Specifications

Generatordimensions

Generatorweight

Hand sealer Tubes diameter Option

232 mm x 91 mm x 91 mm(L x W x H)

2.1 kg

Weight: 0.32 kgDimensions:

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 9MSL3630Additional PVC

hand sealer (PVC tube:

from 2.5 to 5 mm,max 0.75 mmwall thickness)

Generatordimensions

Generatorweight

Hand sealer Tubes diameter Option

232 mm x 91 mm x 91 mm(L x W x H)

2.1 kg

Weight: 0.32 kgDimensions:

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

Ref. 9MSL3622 - Macoseal TWIN EVA Mini 3DSuperior high frequency sealer for EVA tubesand EVA cell freezing and storage bag

Ref. 9MSL3621 - Macoseal TWIN EVASuperior high frequency sealer for EVA tubes

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.

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°29

SEALER

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.

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.

CELL CULTURE

MacoPharma Biotherapy.Bruno Delorme, PhD. R&D Biotherapy Director.

and organs before transplantation. These products enhance safety, traceability and standardisation

p°30

MESENCHYMAL STEM CELLSMC3 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)

. Reduces handling time

. Closed system decreasing contamination risks

. Products equipped with needleless access ports

. Ready and easy to use

. Adapted medium and buffer bags

. Adapted to each step of culture of adherent cells

. Single use products to ensure product quality and security

. Adapted to each step of culture of adherent cells

needleless access ports


. Adapted medium and buffer bags

p°31

CELL CULTURE

MESENCHYMAL STEM CELLSMC3 system: Seeding

Seeding kit - Ref. BC0400011

Specifications

Connections

1 MPC connector2 needleless access ports

1 spike

p°32

CELL CULTURE

MESENCHYMAL STEM CELLSMC3 system: Seeding packages

Seeding packages with CellSTACK®

Specifications

Ref Included itemsCell culture

surface

BC0600011

1 kit BC04000111 CORNING® CellSTACK®

1 chamber1 MPC connector

636 cm2

BC0600021


1 chamber2 MPC connectors

2 x 636 cm2

BC0600031


2 chambers1 MPC connector

1272 cm2

BC0600041


5 chambers1 MPC connector

3180 cm2

Seeding kit BC0400011

MPC connector

CORNING® CellSTACK®

+

+


one chamber


one chamber


two chambers


five chambers

p°33

CELL CULTURE

MESENCHYMAL STEM CELLSMC3 system: Medium exchange

Medium exchange kits

Specifications

Ref Volume Use with: Connections

BC0400021 500 mLCORNING® CellSTACK®

1 or 2 chambers 1 MPC connector1 needleless access port

1 spikeBC0400041 1000 mLCORNING® CellSTACK®

5 chambers

p°34

CELL CULTURE

MESENCHYMAL STEM CELLSMC3 system: Medium exchange packages

Medium exchange packages with MPC connectors

Specifications

Ref Included items

BC06010111 kit BC0400021 (500 mL)

1 MPC connector

BC06010211 kit BC0400021 (500 mL)

2 MPC connectors

BC06010311 kit BC0400041 (1000 mL)

1 MPC connector

+

p°35

CELL CULTURE

MESENCHYMAL STEM CELLSMC3 system: Harvesting

Harvesting kitsSpecifications

Ref Volume Use with: Connections

BC0400031 500 mLCORNING® CellSTACK®

1 or 2 chambers 1 MPC connector3 needleless access ports

1 spikeBC0400051 1000 mLCORNING® CellSTACK®

5 chambers

p°36

CELL CULTURE

MESENCHYMAL STEM CELLSMC3 system: Harvesting packages

Harvesting packages with MPC connectors

Specifications

Ref Use with:

BC06020111 kit BC0400031 (500 mL)

1 MPC connector

BC06020211 kit BC0400031 (500 mL)

2 MPC connectors

BC06020311 kit BC0400051 (1000 mL)

1 MPC connector

+

p°37

CELL CULTURE

MESENCHYMAL STEM CELLSMC3 system: Media

MEM alpha medium in EVA bag

DMEM medium in EVA bag

Specifications

Specifications

Ref Volume Use with:Storage

TemperatureShelf life

BC0110010 270 mLCellSTACK®

one or two chambers

GMP PRODUCT for clinical

applications


12 monthsBC0110020 675 mLCellSTACK®

five chambers

BC0110021 1 L

connections 1 female luer / 1

male luer / 1 twist-off, 1 injection site

Ref Volume Use with:Storage



one or two chambers

GMP PRODUCT for clinical

applications


8 months

Connections: 2 outlet ports

p°38

CELL CULTURE

MESENCHYMAL STEM CELLSMC3 system: Buffer

Phosphate Buffered Saline solution (PBS) in EVA bag

Specifications

Ref Volume Use with: ConnectionsStorage



one or two chambers GMP PRODUCT for clinical

applications

2 outlet ports


12 months


five chambers



p°39

CELL CULTURE

MESENCHYMAL STEM CELLSMC3 system: Transfer bags

Transfer EVA bags

Specifications

Ref Volume Connections

BC0300011 150 mL2 twist off

1spike1 needlelessaccess port

1 injection site1 male luer

BC0300021 350 mL

BC0300031 500 mL

BC0300041 1000 mL

Ref BC0300011

Ref BC0300021

Ref BC0300031

Ref BC0300041

p°40

CELL CULTURE

Macopharma has developed in collaboration with a French blood centre a system dedicated to the preparation of platelet lysate in 3 steps.


. Closed system decreasing contamination risks. Adapted to GMP production. Cost effective technique

STEP 1

Freezing andCentrifugationRef. GSR5050AU

FiltrationRef. BC0800010

DistributionRef. GNR1000AU

STEP 2 STEP 3

MESENCHYMAL STEM CELLSPlatelet lysate preparation kit

Specifications

Ref Volume Temperature of storage Connections Shelf life

GSR5050AU 500 mL -80°C to +40°C

1 spike1 male luer

1 outlet1 injection site

1 needleless access port

2 years

Ref Volume Filtration Connections Shelf life

BC0800010 500 mL Porosity of the filter: 0.65 µm

Sterile connection1 spike 1 year

Ref Bags Volume Temperatureof storage Shelf life

GNR1000AU 9 EVA bags

10 mL to 30 mL per bag -80°C to +40°C 5 years

p°41

CELL CULTURE

MESENCHYMAL STEM CELLS Bone Marrow collectionFor collection and transfer in the operating theatre

Bone marrow transfer / collection bag - Ref. MSE0100Q


Anticoagulantsolution

Connection Shelf life

Up to450 mL

50 mL ACD Female luer 1 year

Fillcollection

Connection Shelf life

Up to1000 mL

Female luer 5 years

Specifications

Bone marrow transfer / collection bag - Ref. VSE6002Q

Specifications

30 cm

35 cm

p°42

Volumeof collection

Connections Shelf life

Up to 40 mL2 female luers

1 male luer1 way-permanent clamp

5 years

Specifications

Bone marrow container / collection bag - Ref. MSM0000XU

MESENCHYMAL STEM CELLS Bone Marrow collectionFor collection and transfer in the operating theatre

CELL CULTURE

p°43

CELL CULTURE

HEMATOPOIETIC STEM CELLSMedia

HP01 in bottle - Ref. BC0100010

HP01 in EVA bag - Ref. BC0100030

Specifications

Specifications

Volume of medium

Packaging UseStorage


500 mL PET bottle


applications


12 months

Volume of medium

UseStorage

TemperatureShelf life Connections

1000 mL


applications


12 months



p°44

CELL CULTURE

CO-CULTURE BAGNew generation of culture bag

Co-Culture bag - Ref. BC0900010

Specifications

Volume

2 compartments Top : 400 mL for mediumBottom : 20 mL for cellsDiscoutinious welding for

exchanges

p°45

. 3D Bag

. GMP product

. Closed system

. Easy to use

CELL CULTURE

p°46

COMING SOON IN 2014NEW!

CELL CULTURE: PANCREATIC ISLETSPRISM SYSTEM

PRISMaAutomated system designed to control medium perfusion,medium exchangeand islet harvesting

PRISMdDevice to workin a closed systemand to improve pancreaticislet preservation

PRISMmDefined andready-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°47

PANCREATIC ISLETSMedia

PrisM in EVA bag Ref. BC0130020

SpecificationsVolume of medium

UseStorage


1500 mL


applications


8 months

PrisM in bottle

Specifications

RefVolume of medium

Packaging UseStorage


BC0130030 500 mL

PET bottle


applications


8 months

BC0130010 1000 mL

CELL CULTURE

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.

PHOTOPHERESIS

MNC collection

8-MOP addition

UVA illumination

++

p°48

PHOTOPHERESIS

THERAFLEX-ECPExtracorporeal Photochemotherapy

UVA illumination EVA bag - Ref. XUV8501Q

8-MOP solution - Ref. CSL1800XA

Macogenic G2 UVA illumination device - Ref. 9MG2000

Specifications

Specifications

Specifications

Nominal volume Volume Connections

3 L 300 mL1 spike

1 injection site

DimensionsIncluded items

and optionsWeight

87 cm (width)x 64 cm (depth)x 37 cm (height)

Printers, scanner, LCD colour touch

screen65 kg

Volume Composition

5 mL

Chemical composition for 100 mL of solution:

Methoxalen...............................................2 mgEthanol (96%)......................................3230 mgGlacial acetic acid...............................230 mgSodium acetate thrihydrate...................860 mgSodium chloride......................................40 mgWater for injections.................................100 mL


AMM PTA N°: TA 07.10.109

p°49

TRANSPLANT

p°50

The current worldwide need to improve graft performance after organ and tissue transplantation

is still unmet. In partnership with academic research teams in France,

Macopharma developed organ preservation solutions and medical devices designed to support transplantation teams

in obtaining better patients’ outcomes.

The preservation solutions contain innovative compounds that minimize graft injury during transportation, storage and preservation. Our ergonomic and sterile medical

devices are designed and adapted to facilitate organ and tissue collection in

a surgery theatre.

TRANSPLANT

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ORGAN CONSERVATION SOLUTION

SCOT 15 solution for abdominal multi-organs

SCOT 15 Multi-organ abdominal in bottle - Ref. BT0200070

SCOT 15 Multi-organ abdominal in EVA bag - Ref. BT0200080

Specifications

Specifications

Description Storage

Extracellular-type solutionTemperature 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.

Hypothermic perfusion and preservation of organs

Colloid: Polyethylene glycol (PEG) 20 kD at 15 g/L

Volume Usage Shelf life

1000 mLSolution to perfuse, preserve and transport

abdominal organs at low temperature 12 months

Volume Usage Shelf life

1500 mLSolution to perfuse, preserve and transport

abdominal organs at low temperature 12 months

AMM PTA N°: TA 08.11.129


TRANSPLANT

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ORGAN COLLECTION

Exsanguination line / bag for multi-organ retrieval - Ref. BT0700040

Specifications

Volume of use Connections

15 LFilling by gravity

Cannula with 2.5 m tubing + 1 clamp

TRANSFERT SET*

p°53* On-demand production

TRANSFERT SET

SAMPLING SET

Sample collection (PVC)

Specifications

Specifications

Reference Volume Language Shelf life Packaging

VSE0001Y 100 mL En 5 years20

Reference Volume Language Shelf Life Packaging

VSE0000A

40 mL

FR

5 years 20VSE0000Y FR

VSE0000YK EN

VSE0000YL PT

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TRANSFERT SET

SIMPLE TRANSFER SET

300 mL (PVC)

Specifications

Specifications

Reference Composition LanguageShelf life

(year)Packaging

VSE4001Q

Spike

EN - FR 5 35

VSE4001XA FR 5 30

VSE4001XB EN 5 35

VSE4001XP PL - ISBT 5 35

VSE4002XB Bung UNIVERSAL 5 35

VSE4101XR

Spike

IT - ISBT 5 30

VSE6003QS ES 5 15

VSE8000XL PT - ISBT 5 15

VSE8001XL PT - ISBT 5 35

VSE8001XQ Female LuerEN - FR - GER

- DUT5 30


VSE2001L

Spike

PT - ISBT

5 years

40

VSE2001XA FR 30

VSE2001XL PT - ISBT 40

VSE2001XQ EN - FR 60

VSE2001XR IT - ISBT 40

600 mL (PVC)

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TRANSFERT SET

SIMPLE TRANSFER SET

1000 mL (PVC)

Specifications

Reference Volume Composition Language Shelf life Packaging

VSE6001Q 1000 mL Spike EN-FR 5 35

VSE6041XA 1000 mL Luer FR 5 15

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TRANSFERT SET

POOLING BAG

600 mL (PVC) Specifications

Specifications

Reference Volume Composition Language Packaging Shelf life

VSE6002XR 1000 2 Spikes IT - ISBT 30 5

VSE6002Z 1000 2 Spikes FR 25 5

VSE8001XB 1000 2 bungs EN - ISBT 25 5

VSE8014xa 3000 4 spikes FR 15 5


VSE3010XD 6 bungs EN 5 20

VSE4002XA 2 Spikes FR 5 30

VSE4011A VSE2001L FR 5 20

VSE4110XA VSE2001L FR 5 15

VSE8003XQ VSE2001L EN - FR - GER - DUT 5 15

VSE8004XB VSE2001L EN 5 20

VSE8004XQ VSE2001L EN - FR - ISBT 5 20

1000 mL and more (PVC)

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TRANSFERT SET

DISTRIBUTION SET

Double set for distribution (PVC)

Specifications

Specifications


VDE3011XA 400 Spike FR 255

VDE4003XA 500 2 bungs FR 25

1000 mL and more (PVC)


VRE4001XA 500Spike

FR 205

VRE7000XQ 500 FR 25

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TRANSFERT SET

DISTRIBUTION SET

Quadruple bags (PVC) Specifications

Specifications


VQE2001A 300 Spike FR 15

5

VQE2001XQ 300 Spike EN-FR 15

VQE6001XB 600 Bung EN 20

VQL0001XC 150 Bung FR 25

VQL0001XU 150 BungUNIVERSAL +

ISBT25

VQX0001XU 150 Spike FR 25

VQX0002XU 150 Spike EN 15

VQX0003XU 100 Spike EN 20 4

Sextuple set (PVC)


VXX2001XB 300 Spike EN 15

5VXX6001XB 600 Bung EN 15

VXX6002XB 600 Bung EN 15

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TRANSFERT SET

PHLEBOTOMY SET

Collection volume : 600 mL (PVC)

Specifications

Specifications

Reference Language Packaging Shelf life

VSL7000PQ

FR

20 5

VSL7000YQ

VSL7000YD

VSL7001PQ

VSL7001PD EN

VSL7002PQ FR

Reference Volume Language Packaging Shelf life

VSL8000XQ

3500

EN - FR - GER - DUT

15

5VSL8000YQEN - FR - GER -

DUT20

VSL8001XQEN - FR - GER -

DUT20

ASCITE

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TRANSFERT SET

TRANSFER CONNECTIONS AND SYSTEMSSpecifications


EPE1017A 9 S - 1 S EN 20

5EPE1018A 12 S - 1 L FR 15

EFL0002XU 5 S - 1 S EN 30

SIMPLE TRANSFER SETSpecifications


EPF0004C 1 N - 1S GER 125

5EPF0005A 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 203

EFL0006XU 1 S - 1 L EN 20

POOLING SYSTEMS

Specifications


ESL0001GUEN

3005

EFL0001DU 500

Collection LineSpecifications

Reference Compostion Language Packaging Shelf life

EFL0000XC 20 m Tubing GER 10 2

EFL0000XD 20 m Tubing EN 10 5

EFL0000Y FR 100 5

EFL0001XC 20 m Tubing GER 10 2

EFL0007XU 12 m Tubing EN 15 5

Tubings

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Macopharma (Maco3)rue Lorthiois59420 MouvauxFranceTel : + 33 (0) 320 11 84 30

Maco Productions (Maco1)200 Chaussée Fernand Forest59200 TourcoingFranceTel : + 33 (0) 320 11 84 00

Maco Productions (Maco5)12 rue du Vertuquet59960 Neuville-en-FerrainFranceTel : + 33 (0) 359 03 44 00

Macopharma PoloniaS.P.Z.O.O.Ul. Szwajcarska 2254-405 WroclawTel : + 48 71 37 60 110

Maco Productions Tunisierue El Houdaybya2036 La SoukraTel : + 216 70 682 060

Macopharma (UK) Ltd.8th Floor - Regal House70 London RoadTwickenham - MiddlesexTW1 3QSUnited KingdomTel : + 44 (0) 20 8892 2922

Macopharma International GmbHRobert-Bosch-Strasse 11D-63225 LangenGermanyTel : + 49 (0) 6103 900 800

Macopharma BeNelux sprl/bvba88, avenue RoyaleB-7700 Mouscron/ MoeskroenBelgiumTel : + 32 (0) 56 84 12 86

Macopharma Nordic ABSödra Strandgatan 4252 24 HelsingborgSwedenTel : + 46 (0) 42 176 340

Macopharma USA3675 Crestwood Parkway,#260 Duluth, GA 30096Tel : + 1 770 270 6867

Macospania S.LAvenida de la Vega, 1Oficina 16 – Edificio 3 – 3ra planta28108 AlcobendasMadrid - SpainTel : + 34 91 521 48 56

Macopharma Italia S.T.L.Viale de Gasperi, 8520017 RHO (MI)Tel : + 39 02 93 909 531

Macopharma Australia PTY LTDPO BOX 5547West Chatswood NSW 1515AustraliaTel : + 61 2 9904 7303

Macopharma Nederland B.V.Orteliuslaan 8503528 BB UtrechtNederlandTel : + 31 30 265 1739

Macopharma Canada Inc.1080 Beaver Hall, Suite GR-002Montreal (QC) H2Z 1S8Tel : + 1 514 868-2222

[email protected]

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BIOTHERAPY

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