MultiSyn

Compact multi-synthesis radiosynthesizer

The MultiSyn is the most compact, versatile and easy to use disposable cassette radiosynthesizer.

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Multi-Isotope

One synthesizer for all your radiochemistry needs.

Lu

177

Zr

89

Sc

47

F

18

Cu

64

Pb

212

Ga

68

Tb

161

I

124

Ac

225

Standardize and simplify your labs radiochemistry requirements with the one versatile synthesizer.  By simply changing the hardware cassette, you can easily switch to another radiosynthesis without any cross-contamination.

 

Typical Synthesis Route

The MultiSyn can perform the following synthetic steps, or you can setup your own method by simply modifying the hardware cassette and synthesis recipe.

Step 1A:

Elution of the isotope to the MultiSyn

Step 3:

Labelling reaction

Step 4:

S.P.E. purification and reformulation of the labelled product

Step 2:
(Optional)

Pre-purification of the eluted/delivered isotope

Step 5:

Final injectable radiotracer

Cyclotron

F-18

Cu-64

Zr-89

Lu-177

Ac-225

Ga-68

Step 1-B:

 Delivery of the isotope to the MultiSyn

Optimized synthesis recipes

Cassettes & Reagents available

Radiotracer recipe files provided free of charge to all users.

Radiotracer

Yield

(not corrected)

Synthesis time
(minutes)

Radiotracer

Synthesis time
(minutes)

Yield

(not corrected)

18F

 

 

 

 

68Ga

68Ga-PSMA

81%

15

18F-FDG

72%

23

68Ga-DOTATATE

75%

17

18F-NaF

96%

3

68Ga-DOTA-exendin-4

64%

25

18F-PSMA

55%

33

68Ga-FAPI

66%

23

18F-FAPI

25%

35

18F-FCH

coming soon

 

177Lu

 

 

177Lu-PSMA

97%

20

89Zr

 

 

177Lu-DOTATATE

>95%

35

89Zr-Durvalumab

75%

30

177Lu-Trastuzumab

88%

65

89Zr-Crefmirlimab Berdoxam

76%

45

225Ac

 

 

225Ac-PSMA

>95%

 

225Ac-DOTATATE

>95%

 

89Zr-DFOsq-TATE

91%

 

89Zr-DFOsq-PSMA

90%

26

89Zr-DFOsq-Gmab

93%

 

161Tb

 

 

161Tb-PSMA-I&T

>95%

30

64, 67Cu

 

 

64, 67Cu-SARTATE

65%

22 / 42

124I

 

 

124I-AT-01

65%

24

Need a compound that is not listed?

 

Contact our team and we can explore the development of custom cassettes and reagent sets.

Disposable Cassette

 

The hardware cassettes and reagent sets helps avoid cross-contamination and ensures reproducible results

 

This enables you to effortlessly meet the most stringent quality control and GMP compliance standards

 

Hardware cassettes are gamma sterilized and come with Certificate of Conformance.

 

By using non-proprietary components, the user can modify and develop their own cassettes.

 

Low metal contaminant materials are used.

 

Lower your labs consumable costs with low priced cassettes and reagents.

 

Hardware cassettes are purchased from iPHASE technologies.

 

Manufactured in Australian GMP clean rooms.

Reagent Set


 Reagent sets purchased from iPHASE technologies manufactured by Huyai or ABX.

 

Each batch of reagents comes with Certificate of Analysis.

Lowest cost consumables in the industry!

Ga-68 Versatility

Compatible with all Ga-68 Generators.

The MultiSyn is compatible with all commercial 68Ga generators.

 

The MultiSyn has a built-in force limiting syringe drive for generator elution and can perform no pre-purification, as well as cationic or anionic pre-purification of the generators eluate.

HCl

Direct

Saline

SCX

Direct Elution Labelling

The simplest 68Ga synthesis method involves direct labelling of the generators eluate.

 

This method reduces synthesis time and simplifies system setup.

Generator Pre-purification

 

Certain reactions require reduction of the acid concentration of the generator eluate and or purification of metal impurities (such as 68Ge) from the eluate to improve reaction conditions.

 

This is easily accomplished with generator pre-purification and involves trapping the generator eluate onto a purification cartridge and subsequent elution to the reactor with a >99% trap and release efficiency of 68Ga.

 

 

Multiple Generator Elution

The MultiSyn can be used to elute multiple generators to increase final radiotracer activity.

 

The process is automated. No need to rotate any taps manually.

Lutetium-177, Actinium-225, Lead-212 & Terbium-161

Theranostic capabilities

The MultiSyn enables the radiochemist to easily synthesize the following theranostic agents with high isotope recovery.

 

177Lu-PSMA
177Lu-DOTATATE

161Tb-PSMA-I&T

225Ac-PSMA-IT
225Ac-HA-DOTATATE

 

177Lu-PSMA / DOTATATE setup

Copper-64 & 67

Novel applications

Easily develop novel methods such as copper radioisotope radiolabelling with the MultiSyn for bot PET imaging and theranostic applications.

 

"Results show that a consistent, efficient and reliable automated method for the manufacture of 64Cu-SARTATE and 67Cu-SARTATE using the MultiSyn radiosynthesiser has been developed, which results in a high yield of product suitable for use in clinical trials, that can be compliant to GMP requirements" ...... Clarity Pharmaceuticals

 

Fully automated synthesis of [64&67Cu] SARTATE on the MultiSyn

Flourine-18

Not just for radiometals

In addition to the radiometal radiolabelling capabilities of the MultiSyn, 18F compounds can also be synthesized such as:

 

18F-FDG

18F-NaF

18F-PSMA
18F-FAPI

 

 

Cassette has been tested with up to 480 GBq (13 Ci) of starting 18F for FDG resulting in a 66% uncorrected radiochemical yield.

18F-FDG setup

Zirconium-89
Monoclonal antibody radiolabelling

Fully automate 89Zr monoclonal antibody radiolabelling using the MultiSyn.

 

Typical fully automated synthesis process involves:

 

1. Automated cartridge conditioning

2. 89Zr Neutralization

3. Radiolabelling

4. Purification using PD-10 cartridge

 

MultiSyn Solid Target
Dissolution Expansion Module

The MultiSyn solid target dissolution expansion module will enable the MultiSyn to be a complete system for the closed-circuit dissolution of coin based solid targets (64Cu, Zr89 & 68Ga) and purification of the dissolved isotope on the MultiSyn's disposable cassette.

 

 

 

Coin based Solid Target Dissolution & Purification Process:

 

 

Target Dissolution:

  1. MultiSyn pressure tests expansion module's fluidic circuit
  2. MultiSyn transfers reagents to expansion module
  3. Drop irradiated target into funnel
  4. Clamp coin to seal target face
  5. Peristaltic pump circulates heated acid to dissolve target

 

 

Target Purification:

  1. MultiSyn transfers dissolved target from Expansion Module
  2. Cartridge purification of dissolved target on MultiSyn's disposable cassette

Cu

Ga

Zr

68

89

64

 Dimensions:
21 x 10 x 18cm (HxLxD)

2 Options for location of Expansion Module:

 

  • The expansion module is locate next to the MultiSyn in the same hotcell.  This setup requires a transport system for irradiated coin to the hotcell.

 

or

 

  • The expansion module is located underneath solid target in the cyclotron bunker for direct dropping of coin into expansion module's receiving funnel.  This setup does not require a transport system and only one 1/16" tube connection between the MultiSyn and Expansion Module is required.

Targets:

 

The MultiSyn solid target dissolution module is compatible with the following targets.

 

24mm diameter circular target.

24mm x 40mm rectangular targets mounted to a backing disk up to 3mm thick.

If you require specific shape target contact us.

Radiation detector monitoring:

 

1 x Radiation Detector located in the Expansion Module to monitor dissolved solution radioactivity.

 

3 x Radiation Detectors in the MultiSyn for purification process monitoring.

External Control Electronics

Eliminate radiation damage

The MultiSyn's PLC (programmable logic controller) electronics are housed in an external enclosure located outside of the hotcell.

 

This eliminates the possibility of damage to the electronic components due to high radiation fields thereby significantly increasing system reliability.

Compact Dimensions

Easily install multiple synthesizers in the one hotcell.

Width 27.5cm  x  Height 39.7cm  x  Depth 24cm

Open User Interface

System control & visual synthesis recipe development all in one platform.

Open software provided free of charge to all users.

The user interface combines both powerful features, yet easy to use tools for both daily operation and synthesis recipe development.

  • Easy to use open software interface for easy tracer development
  • Guides you step-by-step during the synthesis
  • Can be installed on multiple computers for remote synthesis
  • Recording of all process variables and report generation (21 CFR Part 11 & GMP compliant)
  • Traditional PC or Touch Screen Tablet Control
  • Built-in remote diagnostics enabling simplified troubleshooting
  • Open software system comes standard at no extra cost to the user

Synthesis Reports

Generate and print synthesis reports to satisfy you labs documentation and GMP requirements

Real-Time Sensors Trends

All sensor information can be displayed graphically in real-time trends

Historical Data Review

Review previous synthesis results as trend graphs with data analysis function

Graphical Synthesis Recipe Development

Click • Define • Save

SAVE STEP

1. Click Schematic

Click schematic elements such as solenoid valves and rotary actuators to turn them on/off or to set positions.

2. Define parameter

Define parameters such as reactor temperatures, syringe volumes & step parameters (description, time, condition).

3. Save Step

Click the Save Step button and the software will automatically fill-in the Excel recipe step list automatically.

Synthesis recipes are stored as easily editable Excel step list files

MultiSyn Users

Some of the institutions that are using the MultiSyn.

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