Radiochemistry

Overview

Our radiochemistry team has successfully radiolabeled hundreds of biological agents and small molecules and submitted over 80 INDs for clinical use of novel radiotracers. This wide range of chemical entities has included CNS-penetrant small molecules, monoclonal antibodies, peptides, intrathecally administered molecules, virus and live cell labeling, and heart and blood targeting agents.

In addition to radiochemistry services, we also offer ligand design capabilities and medicinal chemistry support for optimization and synthesis of new ligands. This includes an in-house organic synthesis lab and partnered CROs for outsourcing DMPK analysis. In addition to in vitro screening, we also perform in silico virtual screening of existing compound libraries to aid in your ligand selection processes.

Panel Discussion – Theranostics

Info Sheet – Radiopharmaceutical Therapy

Capabilities

Across our multiple sites, we offer the following services for radiotracer support:

Radiohalogenation and radiometallation
Manufacturing for clinical use according to GMP, USP 823, USP 825, and CFR part 212
Deep expertise in automated synthesis module, including GE, Eckert and Zeigler, and ORA systems
Wide range of ligands, ranging from low molecular weight to proteins and biologics.
Ga-68 generator on site
Siemens Cyclone cyclotrons for C-11 and F-18 production
Rapid method transfers between sites
Shipping of manufactured tracers to off-site imaging facilities
Outsourcing tritiation of ligands

In addition to manufacturing capabilities, we provide the following associated quality control services:

HPLC methodology including RP, SE, IE and UPLC
In-house development of bioactivity and immunoreactivity assays
Full metabolite analysis (blood, urine, and brain)
Cell binding, tissue binding and cell internalization assay method development
CMP panel/urine analysis for monitoring metabolic health
UV/Vis spectrophotometer
GC for residual solvent analysis
SDS-page electrophoresis
Gamma counters
Dose calibrator and multi-channel analyzers
Radio-TLC scanners
Audio radiography

Isotopes/Modalities

Invicro has experience working on projects with common SPECT/PET isotopes. We also support conjugation with fluorophores as well as ‘cold’ radiolabeling with non-radioactive elements.

Common SPECT Isotopes

Isotope	Half-Life
^99mTc	6.01 hrs
¹²³I	13.2 hrs
¹¹¹In	67.3 hrs
²⁰¹Tl	73.0 hrs
¹⁷⁷Lu	159.5 hrs
¹³¹I	192.6 hrs

Common PET Isotopes

Isotope	Half-Life
¹³N	10 mins
¹¹C	20.3 mins
⁶⁸Ga	67.7 mins
¹⁸F	67.7 mins
⁶⁴Cu	12.7 hrs
⁸⁹Zr	78.4 hrs
¹²⁴I	4.2 days
⁵²Mn	5.6 days

Other Available Isotopes

Isotope	Half-Life
²¹³Bi	45.6 mins
⁹⁰Y	64.1 hrs
²²⁵Ac	10.0 days
³²P	14.3 days
³H	12.3 yrs
¹⁴C	5730 yrs

Medicinal Chemistry

Invicro offers comprehensive capabilities in small molecule ligand development, by consulting on the use of sponsor-derived ligand libraries or manufacturing custom precursors and standards for preclinical applications. Our in-house expertise in ligand selection criteria and screening helps drive more informed go/no-go decisions for early-phase candidates. Additionally, we provide custom GMP precursor manufacturing through our trusted contracted partners.

Technology Transfer Services

In addition to our in-house radiochemistry services, we also provide oversight of clinical manufacturing from external sites. This includes production and shipment from our New Haven facility to locations across the US, and from our London facility to sites across the UK.

We also offer access to and setup of a worldwide network of radiotracers manufacturers. This is achieved by bringing the chemistry manufacturing to one of our GMP sites before sending our technology transfer teams to the sponsor-identified site to set up the manufacturing process.

We also have experience working with external radiochemistry manufacturers to optimize and bring new tracers with IND applications and NDA for commercial filing.