” The best way to predict the future is to create it “
(Peter Drucker – Professor, author & theoretician)

At macopharma, we believe in innovation to reach our vision to raise the standards of care. From incremental to radical and disruptive we organize with multi-disciplinary experts: our innovation committee.  

What is an innovation?


A new or modified entity that performs or redistributes value(AFNOR, ISO 56000)

The degree of novelty can be expressed by the attributes of an innovation (ISO 56000) :

Incremental innovation : progressive changes (ISO 56000)
Gradual, continuous improvements on existing products, services, processes, … 

Radical innovation: entirely new or significant changes (ISO 56000)​
is at the other end of the value chain compared to incremental innovation​
Ex: technological breakthrough that transform industries – can create new market​

Disruptive innovation: replaces established offers (ISO 56000)​ 

As one of the main actors in the promotion of platelet concentrates preparation, our mission is to understand customers’ needs and provide solutions to help them produce the most qualitative and safe products. Our observation on the platelets’ pooling process led us to the conclusion that platelet concentrates preparation is currently time-consuming, demanding and complex. In order to complete its offer and optimize platelet preparation process, Macopharma has therefore designed Maconnect, the very first multiple sterile connection device

Its one-step procedure
allows up to

0

connections

The time needed to connect
a pool of Buffy Coat is less than

0

seconds

0
The very first multiple sterile connection device

Especially designed for pooling operations

Maconnect is a unique and innovative concept, especially designed to optimize, simplify and step up the platelets preparation process, while guaranteeing the preparation of a safe platelet concentrate.

Maconnect is the very first multiple sterile connection device, especially designed for pooling operations.

Its one-step procedure allows the connection of up to 12 tubes.

Connecting one pool of platelets with one single blade and device.

With one Maconnect and one blade, only 30 seconds are needed to connect one pool of Buffy Coat.

The MacoSeal Light is the new innovation by Macopharma, a cordless sealer with an extended battery autonomy, a unique compact lightweight shape and an outstanding intuitive sealing button enabling every usage configuration. 

The remarkable design of the MacoSeal Light was meant to increase the device capabilities while optimising its ergonomics and reducing manual efforts. 

1g
Weight
0h00
Complete battery charge
0
Sealings per battery charge

No compromise:

Macopharma bans DEHP, to ensure SAFE and SECURED

blood component solutions to every patient in the world!

Full compliance with REACH regulation

Complete engagement to switch to non-DEHP

More than words, we commit to act and respect our mission:

We support life !

At Macopharma,
we consider Non DEHP
transition as INNOVATION.


Because the value of future bag systems is about safety
we have dedicated a full team of scientific experts to research,
design and develop our new kits as a pure
INNOVATION.

Chemical considerations

Complete hydrolysis in vivo2, unlike DEHP

Water solubility far superior to DEHP3 (> 103 times)

Improved toxic profile with no mutagenic, carcinogenic or reproductive effects1,4

Less leaching than DEHP5-7

Usually used within 20-24 days after collection

Alleviate environmental hazard risks

(1) Wirnitzer U, Rickenbacher U, Katerkamp A, Schachtrupp A. Systemic toxicity of di-2-ethylhexyl terephthalate (DEHT) in rodents following four weeks of intravenous exposure. Toxicology Letters 2011; 205 (1): 8-14.

(2) Carlson KR. U.S. Consumer Product Safety Commission (CPSC). Toxicity Review for Di-2-ethylhexyl Terephthalate (DEHT). Risk Science Center Department of Environmental Health, University of Cincinnati, 2018.

(3) SCENIHR (Scientific Committee on Emerging and Newly-Identified Health Risks), Scientific Opinion on the safety of medical devices containing DEHP-plasticized PVC or other plasticizers on neonates and other groups possibly at risk. 2015.

(4) Kambia N, Séverin I, Farce A, Dahbi L, Dine T, Moreau E, Sautou V, Chagnon MC. Comparative Effects of Di-(2-ethylhexyl)phthalate andDi-(2-ethylhexyl) terephthalate Metabolites on Thyroid Receptors: In Vitro and In Silico Studies. Metabolites 2021; 11:94.

(5) Graminske S, Puca K, Schmidt A, Brooks S, Boerner A, Heldke S, de Arruda Indig M, Brucks M, Kossor D. In vitro evaluation of di(2-ethylhexyl)terephthalate-plasticized polyvinyl chloride blood bags for red blood cell storage in AS-1 and PAGGSM additive solutions. Transfusion 2018; 58:1100-1107

(6) Nielsen BS, Andersen DN, Giovalle E, Bjergstrøm M, Larsen PB. Alternatives to classified phthalates in medical devices. Dan. Minist. Environ. 2014.

(7) Thelliez et al. Migration of di(2-ethylhexyl) phthalate, diisononylcyclohexane-1,2-dicarboxylate and di(2-ethylhexyl) terephthalate from transfusion medical devices in labile blood products: A comparative study. Vox Sang 2023; 118(7):533-542.

PAGGSM* vs SAGM**

* Phosphate-Adenine-Glucose-Guanosine-Saline-Mannitol
** Saline-Adenine-Glucose-Mannitol


Incorporation of PAGGSM in DEHT-based RBC storage bags significantly attenuates haemolysis and enhances key red blood cell quality indicators.1,2

PAGGSM has been used for decades in Germany and enabled to increase the storage time from 42 to 49 days3,4

No impact on clinical effectiveness and patient’s safety reported (Germany, Switzerland)

(1) Larsson L, Sandgren P, Ohlsson S, Derving J, Friis-Christensen T, Daggert F, Frizi N, Reichenberg S, Chatellier S, Diedrich B, Antovic JP, Larsson S, Uhlin M. Non-phthalate plasticizer DEHT preserves adequate blood component quality during storage in PVC blood bags. Vox Sang 2021; 116:60–70.

(2) Graminske S, Puca K, Schmidt A, Brooks S, Boerner A, Heldke S, de Arruda Indig M, Brucks M, Kossor D. In vitro evaluation of di(2-ethylhexyl)terephthalate-plasticized polyvinyl chloride blood bags for red blood cell storage in AS-1 and PAGGSM additive solutions. Transfusion 2018; 58:1100-1107

(3) Hess J. Extended Liquid Storage of Red Blood Cells. In: Blood Donors and the Supply of Blood and Blood Products. Manning FJ, Sparacino L, Eds. Washington DC: The National Academies Press, 1996.

(4) Flegel WA, Natanson C, Klein HG. Does prolonged storage of red blood cells cause harm? Br J Haematol 2014; 165:3-16.

DEHT x PAGGSM performances

EFS/SFS study

All plasma and RBC units were compliant with the EDQM requirements (21 Ed.), at D1

During the storage of plasma, at 6 and 12 months, Fibrinogen Factor VIII, and Total Proteins, were compliant with the EDQM.

When comparing DEHT/PAGGSM and DEHT/SAGM, the parameters controlled during RBC storage, from D1 to D49, were similar (pH, glucose, lactate and potassium).

For haemolysis, at d49, 100% of RBC/PAGGSM units were compliant with the EDQM requirements, versus 87% of RBC/SAGM (p < 0.05). Nevertheless, all RBCs were compliant until D42.

ATP results improved with the PAGGSM solution (D35, D42, D49; p < 0.05).

(1) Wirnitzer U, Rickenbacher U, Katerkamp A, Schachtrupp A. Systemic toxicity of di-2-ethylhexyl terephthalate (DEHT) in rodents following four weeks of intravenous exposure. Toxicology Letters 2011; 205 (1): 8-14.

(2) Carlson KR. U.S. Consumer Product Safety Commission (CPSC). Toxicity Review for Di-2-ethylhexyl Terephthalate (DEHT). Risk Science Center Department of Environmental Health, University of Cincinnati, 2018.

(3) SCENIHR (Scientific Committee on Emerging and Newly-Identified Health Risks), Scientific Opinion on the safety of medical devices containing DEHP-plasticized PVC or other plasticizers on neonates and other groups possibly at risk. 2015.

(4) Kambia N, Séverin I, Farce A, Dahbi L, Dine T, Moreau E, Sautou V, Chagnon MC. Comparative Effects of Di-(2-ethylhexyl)phthalate andDi-(2-ethylhexyl) terephthalate Metabolites on Thyroid Receptors: In Vitro and In Silico Studies. Metabolites 2021; 11:94.

CBS/NETCAD study

Whole blood-derived red blood cell concentrates, collected and stored in prototype DEHT/PAGGSM collection sets, show acceptable quality until expiry at 42 days

Overall, in vitro quality of “warm” RCCs in DEHT/PAGGSM indicated:

No failures against current Canadian Blood and Blood Components Quality Control criteria, for LR-RCC in DEHP/SAGM, at expiry.

No significant difference in haemolysis between RCCs in DEHP/SAGM and DEHT/PAGGSM at day 43.

Differences seen in ATP and MCV, in line with observations from others and likely due to additive solution change, rather than plasticizer change.

Deformability changes observed, likely related to the absence of DEHP at the RBC membrane.

Walsh GM, Howell A, Stephenson T, Olafson C, Blake J, Sumian C, Reichenberg S, Brebant Q, McTaggart K. AABB 2024, P-BC-38.