Instant radiochemical purity measurements for complex decay chains

The Spec-RAM LC uses high-resolution gamma spectrometry to determine the isotopic composition of radio-HPLC eluents with exceptional precision. It enables users to distinguish parent isotope signals even in complex decay chains where radiochromatographic peaks include daughters. As a result, it provides a unique solution for the Quality Control of 212Pb.

This provides instant, online radiochemical purity measurements and eliminates the need to wait for daughters to decay, collect fractions, and manually handle data.

QC for alpha therapeutics

The Spec-RAM LC is ideally suited to radiopharmaceuticals with complex decay pathways, where daughter isotopes contribute signals within the parent energy window, such as with 212Pb. The instrument was developed in direct response to industry demand for an effective QC solution for 212Pb radiopharmaceuticals, driven by the therapeutic potential of its alpha-emitting daughter, 212Bi.

QC for other gamma emitters

The Spec-RAM LC can also be used as a standard gamma spectrometer for measuring the radionuclidic identity and radionuclidic purity of a wide range of isotopes. Alternatively, it can be used as an online HPLC detector for common isotopes such as 99mTc, 18F, 68Ga, 177Lu and more.

Introducing the Spec-RAM LC+

As part of LabLogic’s ongoing commitment to continuous product development, we are pleased to introduce the Spec-RAM LC+ featuring a bigger detector volume for even greater sensitivity in the same package and footprint as the original Spec-RAM LC.

The Spec-RAM LC+ has even greater efficiency, allowing contributions from 212Bi and 208Tl to be isolated.

Features

CZT Detector

The Spec-RAM LC uses a Cadmium Zinc Telluride (CZT) detector. Because of the high atomic numbers of Cd and Te, CZT is highly sensitive to gamma rays and provides an energy resolution (FWHM) of ≤2.5 % compared to traditional scintillator detectors.

CZT detectors operate at ambient temperature without cryogenic cooling.

Compatible with all HPLCs

The Spec-RAM LC is compatible with any HPLC system, including LabLogic’s Logi-CHROM, allowing users to integrate the gamma spectrometer into existing HPLC workflows. Laura Radiopharma is compatible with all components from the world’s leading manufacturers of HPLC systems, providing a single point of control for your instruments.

Flow cell volumes

A range of fixed volume cells including 10, 20, 50, 100 and 200 µL are available. Additional flow cell volumes are available on request.

QC for Pb-212

The Spec-RAM LC was developed specifically in response to a demand from industry for a solution for the Quality Control of 212Pb radiopharmaceuticals because of the therapeutic potential of its alpha-emitting daughter 212Bi.

In the 238 keV energy window, there are contributions from 212Bi, 208Tl, and 212Pb, but for RCP, only the parent 212Pb is measured. This can be particularly difficult to do using a traditional gamma counter because of the daughter gamma rays scattering, creating a signal inside the 212Pb energy window, even when there is no 212Pb present in the HPLC eluant. Only a detector with sufficient resolution and “above scatter” peak integration such as the Spec-RAM LC can effectively discriminate between the 277 keV gamma from 208Tl and the 238 keV gamma from 212Pb.

Immediate RCP Measurements

The Spec-RAM LC enables in-line quantification, providing direct radiochemical purity measurements. This means no more waiting for the decay of short-lived daughters and no more laborious fraction collecting.

Excellent SNR

The Spec-RAM LC is highly sensitivity thanks to a copper liner that eliminates Compton scattering and a lead shield attenuates background environmental radiation and exposure to the operator. This delivers an excellent signal-to-noise ratio with the detection of low-level peaks at sub kBq levels.

Compact Footprint

With a diameter of only 24 cm, the Spec-RAM LC is a benchtop instrument that is light enough and small enough to sit on any standard laboratory bench.

A compliant solution

The Spec-RAM LC is controlled by Laura Radiopharma, the industry’s standard software for instrument control and data analysis. New updates allow the Spec-RAM LC to use time-resolved gamma spectrometry and innovative peak-finding tools to fully automate radiochemical purity measurements, while ensuring regulatory compliance via controlled access and audit trails.

Audit trail

Laura Radiopharma has a fully featured audit trail that can be configured to suit the requirements of the user’s site. Response from the user can be a simple as choosing from a predefined list of standard audit reasons or require a unique response depending on the situation and site rules.

Access levels

Laura Radiopharmacy features multi-level access control, and the system can be configured to have as many levels of access as the user’s site requires. Menu items are then restricted according to the security level of the individual logged in.

Electronic signatures

Laura Radiopharma supports the use of electronic signatures, and the system can be configured to suit the user sites requirements for electronic data.

Data integrity

Regulatory compliance is an essential feature of Laura Radiopharmacy, built to meet GLP/GMP, FDA 21 CFR part 212 / 11, and EU Annex 11 requirements. Featuring configurable audit trail, electronic signatures, secure data storage in a database environment and multi-level security, Laura Radiopharma can be configured to meet regulatory requirements for data integrity.

Security settings

Laura Radiopharma can be configured to suit your particular site requirements for security. Usernames and passwords can be controlled relative to the site requirements as can inactivity time outs and all other functions required for a secure system.

Nuclide ID

Laura Radiopharma’s Nuclide ID function allows users to simultaneously test radionuclidic identification via a half-life measurement and radionuclidic purity using the Spec-RAM CZT. By measuring decay every 1 second at the same time as performing gamma spectrometry on one sample, a decay chain is visualised on screen in real-time, providing dozens of datapoints within minutes to automatically identify radionuclides.

 

Specifications

Height 277 mm
Diameter 240 mm
Weight 52 kg
Probe Head Dimensions ∅ 24 x 58 mm
Detector Volume 0.5 cm3
Bias Voltage ≤1500
Energy Resolution (FWHM) at 662 keV ≤2.5 %
Peak-to-Compton Ratio at 662 keV ≥4.0
Flow Cell Volumes 10 - 200 µL (additional volumes available upon request)
Background <0.2 cps

Existing Spec-RAM LC users 

Click the tabs below to learn more about our customers and their applications for the Spec-RAM LC.

AdvanCell, Australia

Revolutionising Pb-212 QC

AdvanCell is pioneering Targeted Alpha Therapy, rapidly translating a reliable supply of radiopharmaceuticals using 212Pb to commercial scale. The Australian company has been one of the first adopters of the Spec-RAM LC, using it to supersede fraction collection and gamma counting.

In this video, Chief Scientific Officer Simon Puttick tells us why the burgeoning relationship between AdvanCell and LabLogic is generating increasing excitement for 212Pb radiopharmaceuticals.

You can find out what Simon had to say by watching the video or clicking the button below.

FIND OUT MORE

Orano Med, USA

Instant radiochemical purity analysis

Orano Med is a biotechnology company specialising in the development of new therapies using 212Pb. At this year’s EANM in Barcelona, we sat down with Chief Scientific Officer Julian Torgue to discuss his partnership with LabLogic. Julian spoke about how this new solution for Targeted Alpha Therapies is allowing Orano Med’s Drug Development and Preclinical Unit (DDPU) in Plano, Texas to deliver instant results with greater precision, without having to collect fractions or use a gamma counter.

You can find out what he had to say by clicking the button below or watching our video interview with him.

FIND OUT MORE

Perspective Therapeutics, USA

Developing theranostic platforms using 212Pb and 203Pb

LabLogic Field Service Engineers Afzal Yacoob and Timothy Fujihara install the Spec-RAM LC at Perspective Therapeutics.

Perspective Therapeutics is a clinical-stage radiopharmaceutical company that is pioneering innovative treatments for cancers using 212Pb to deliver powerful radiation directly to cancer cells via high-affinity targeting peptides. These radiotherapies are developed as theranostic platforms by incorporating the radiotracer 203Pb for imaging into the same targeting peptides.

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