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

68Ga

PSMA

81%

68Ga

DOTATATE

75%

177Lu

PSMA

>95%

177Lu

DOTATATE

>95%

18F

FDG

72%

64, 67Cu

SARTATE

65%

89Zr

Durvalumab

75%

89Zr

Crefmirlimab

Berdoxam

76%

161Tb

PSMA-I&T

>95%

225Ac

PSMA-I&T

>95%

225Ac

HA-DOTATATE
>95%

Uncorrected radiochemical yield

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.

Ga-68 Versatility

Compatible with all Ga-68 Generators.

The MultiSyn is compatible with all commercial Ga-68 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

 

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

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

 

Cassettes available.

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 coin (24mm) 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

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.

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 23.8cm  x  Height 39.7cm  x  Depth 24cm

Open User Interface

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

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.

iPHASE Support?

Key aspects of our support structure

Spare Parts

Complete stock of spare parts for all synthesizers are available and can be expressed shipped to you to minimise downtime.

Continuing Education

The field of radiochemistry is

ever changing and our education program is there to ensure your team is fully up to date with our latest developments.

Technical Support

You are always  a phone call or an email away from an experienced iPHASE engineer or staff member to assist with any queries.  Achieving customer satisfaction is our primary objective.

Upgrades

Due to the ever evolving nature of technology, we are continually  following the trends and applying the latest technologies to our systems to increase performance, productivity and reliability.

Remote diagnostics

Remote diagnostics are built into every system we make. This enables our experienced engineers to diagnose, test and guide the user to the quickest solution to an issue should it arise.

Hands on Training

Personalized hands on training will ensure your staff will easily learn and master all aspects of our automated technology.

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