The radiopharmaceutical sector has traditionally grown steadily but modestly, mostly due to its well-established use in nuclear imaging and diagnostics in clinical medicine.
However, there has been a noticeable change in the landscape in recent years. Recent developments in technology, especially in the production of isotopes such as Actinium-225 (Ac-225), are opening new therapeutic uses and extending the clinical potential of radiopharmaceuticals beyond imaging into targeted radiotherapy.
At the same time, increased investment from pharmaceutical corporations, along with strategic alliances among pharma, university research institutions, and CROs, is hastening innovation and shortening development times.
How radiopharmaceuticals work
Targeted radiopharmaceuticals generally consist of four major components: a targeting molecule (such as an antibody), a linker, a chelating agent, and a radionuclide. Similar to antibody-drug conjugates (ADCs), these agents seek to substitute non-specific external beam or systemic radiotherapy with a more selective approach.
The targeting molecule delivers the radiopharmaceutical to specific tissues or organs, where it accumulates in the tumor microenvironment. Once localized, the radionuclide either emits radiation for imaging or delivers high-energy radiation that kills or severely damages malignant cells while minimizing exposure and harm to healthy tissues.
Therapeutic applications
Targeted radiotherapeutics have gained tremendous traction, notably in prostate cancer and neuroendocrine tumors, thanks to a large number of actionable molecular targets, significant unmet clinical needs, and the intrinsic radiosensitivity of these diseases. Emerging advancements are also being investigated in other areas, such as breast and lung cancer, where focused techniques are showing promise.
Personalized treatment options are also being advanced through the combination of diagnostics and medicines, known as theranostics. Theranostics, by using unique diagnostic imaging biomarkers, enables accurate patient selection and treatment protocol customization, thereby improving patient outcomes and increasing overall care efficiency.
PK, immunogenicity, and biomarker analysis – best approaches
Growing regulatory requirements, particularly in radioactive material handling, radiation safety, and environmental compliance, are driving demand for greater expertise across the radiopharmaceutical development process. Synexa Life Sciences has seen an increase in demand for specialist services, notably those involving radioactive specimen management, integrated theranostic trials, imaging investigations, and negotiating complicated regulatory systems.
There are three main bioanalytical techniques for radiopharmaceuticals:
PK analysis
Ligand-binding assays are frequently used to measure drug concentrations in biological matrices, such as plasma, serum, or tissue homogenates, during nonclinical and clinical pharmacokinetic investigations. Sandwich immunoassays, target-capture assays, target-bridging assays, total and free antibody-drug conjugate (ADC) assays, and anti-idiotype (anti-ID) bridging assays are examples of platforms.
Additionally, Synexa facilitates the determination of total radioactivity in research materials. Using these assays, the therapeutic drug can be precisely quantified over time, facilitating crucial assessments of the absorption, distribution, metabolism, and elimination (ADME) profiles required for regulatory submissions and dosage optimization.
Immunogenicity
Immunogenicity testing is carried out at all stages of drug development, particularly at critical regulatory milestones, to assess immune responses to the treatment. Ligand-binding assays (e.g., bridging or direct formats, including acid dissociation techniques), competitive receptor-binding assays, and cell-based assays are used for preliminary screening, confirmation, cross-reactivity evaluation, and characterization of neutralizing antibodies (NAbs).
Detecting and characterizing anti-drug antibodies (ADAs) is critical for understanding possible effects on safety, effectiveness, and pharmacokinetics, and it is a regulatory requirement for biologic therapies.
Biomarkers
Biomarker analysis is conducted on "hot samples" (radioactive tissues) throughout the clinical development phase, generally in conjunction with PK and immunogenicity investigations. MSD (Meso Scale Discovery), ELISA, Gyrolab, RIA, Delfia, and LC-MS/MS techniques are utilized based on the assay's sensitivity, throughput, and sample volume requirements. Biomarkers provide crucial information on the mechanism of action, pharmacodynamic responses, patient stratification, and therapy effectiveness, thereby improving clinical decision-making and supporting regulatory filings.
Safety
Safety will always take precedence in the creation and analysis of radiopharmaceuticals. Given the products' inherent radioactivity, CROs must continually enhance their safety management systems, provide rigorous employee training, and ensure full compliance with radiation protection requirements. Enhanced monitoring and rigorous risk assessment systems are required to protect patients, researchers, and the environment.
As regulatory criteria evolve, especially in radiopharmaceutical safety, isotope handling, and radioactive waste management, CROs must remain alert and proactive to meet these requirements. Although many radiopharmaceuticals have very short half-lives, which reduces overall radiation exposure over time, careful handling and rigorous adherence to safety measures are still necessary.
About Synexa Life Sciences
Synexa Life Sciences is a biomarker and bioanalytical lab CRO, specializing in the development, validation and delivery of a wide range of complex and custom-designed assays.
With a team of over 200 staff across three global laboratory locations; Manchester, Turku (Finland) and Cape Town, we provide innovative solutions to support our customers to achieve their clinical milestones.
Our main areas of expertise include biomarker identification and development, large and small molecule clinical bioanalysis, (soluble) biomarker analysis (utilizing MSD, LC-MS/MS, ELISA, RIA, fluorescence and luminescence-based technologies), cell biology (including flow cytometry, ELISpot and Fluorospot) and genomic services to support clinical trials and translational studies.
We pride ourselves on our deep scientific expertise and ability to tackle complex problems, translating them into robust and reliable assays to support clinical trial sample analysis.
Since 2019, Synexa has been backed by Gilde Healthcare, a specialized healthcare investor. Synexa, improving the quality of human health through innovative biomarker and bioanalytical solutions.
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